ers from the...AMERICAN HOME PRODUCTS CORP. 1525 1524 Complaint shrink, avoid need for sUl'gical treatment on, heal, cure, or remove hem- orrhoids or effect any other cure beyond temporary

1524 FEDERAL TRADE COMMISSION DECISIONS

Syllabus 70 F. T.

FINAL ORDER

The parties having entered into a stipulation filed on May 271966, providing, inte,' alia that: the case would be submitted tothe Commission on the record in Docket 8641 American HomeProducts Corpomtion (p. 1524 hereinJ and such other facts andrecords as provided for in said stipulation; that the facts applica-ble to the case support the stipulation that the advertisements inthe case had no significantly different effect upon readers or hear-ers from the effect of the advertisements in American HomeProducts and that the effect of the use of respondent's prepara-tion is not significantly different from the use of American HomeProducts' preparations; that to the extent that respondent's ad-vertisements differ significantly from those in A meriean HomeProducts the Commission may, in its order disposing of this pro-ceeding, include appropriate provisions to take into consideration

such differences; that respondent waives any intervening stepsbefore the hearing examiner; that the Commission may, on thebasis of this stipulation , the advertisements attached thereto andthe record in American Home Products issue such order as itdeems necessary in the public interest and that the record on

which the Commission is to make its disposition of this proceed-ing is limited to the record at the time this stipulation is filed;and the Commission having rendered its decision and issued itsOpinion herein;

:!ow therefore , on the basis of said stipulation and attach-ments , the pleadings herein and the record in Docket 8641 A mer-ican Home Products Corporation (p. 1524 hereinJ, it is hereby

O,"dered That the attached Findings of Fact , Conclusions andOrder be and they hereby are entered and issued by the Commis-sion in final disposition of this proceeding.

IN THE MATTER OF

AMERICA:! HOME PRODL'CTS CORPORATION

ORDER, OPINION, ETC. , IN REGARD TO THE ALLEGED VIOLATION OFTHE FEDERAL TRADE CO !M!SSION ACT

Docket 8641. Complnint , Aug. 1.9fi4-DecisioJI , Dec. 1%0*

Order requiring a New York City manufaeturer of " Preparation H" oint-ment to cease falsely representing in its advertising that its product wil

"Modified on ,July 15 , 196n and June 9 , 1970.

AMERICAN HOME PRODUCTS CORP. 1525

1524 Complaint

shrink , avoid need for sUl'gical treatment on , heal , cure, or remove hem-orrhoids or effect any other cure beyond temporary relief.

COMPLAINT

Pursuant to the provisions of the Federal Trade CommissionAct, and by virtue of the authority vested in it by said Act , theFederal Trade Commission , having reason to believe that Ameri-can Home Products Corporation , hereinafter referred to as re-

5pondent, has violated the provisions of said Act , and it appearingto the Commission that a proceeding by it in respect thereof

would be in the public interest , hereby issues its complaint stat-ing its charges in that respect as fol1ows:

PARAGRAPH 1. Respondent American Home Products Corpora-tion is a corporation organized , existing and doing business underand by virtue of the laws of the State of Delaware with its princi-pal offce and place of business located at 685 Third A venue in thecity of New York , State of New York.

PAR. 2. Respondent _4merican Horre Products Corporation isnow and for more than one year last past has been , engaged inthe sale and distribution of preparation offered for the treatmentof piles or hemorrhoids and coming within the classification ofdrugs as the term "drug" is defined in the Federal Trade Commis-sion Act.

The designation used by respondent for said preparations , theformulae thereof and directions for use are as fol1ows:

Designat-ion: Preparation H" Ointment.

Formula: The active ingredients fo)' Preparation H Ointment are as fol-10ws: Live Yeast CeJl Derivative , Supplying 2 000 units, Skin RespiratoryFactor (Rio-Dyne) Per Ounce of Ointment; Shark Liver Oil 3.0%; Phenyl-mercuric Nitrate 1: 000 in a Specially Prepared Rectal Ointment Base.

Directions: Apply freely night and morning and after each bowel move-

ment. Lubricate applicator before each application and thoroughly cleanse

after use. Rectal conditions are more rapidly improved by continual applica-tion. In case of bleeding, a physician should be consulted. Keep all medicinesout of the reach of children.

Designation: Preparation H" Suppositories.Formula: The active ingredients are Live Yeast Cell Derivative , supplying000 units Skin Respiratory Factor (Rio-Dyne) Per Ounce of Suppository

Base; Shark Liver Oil 3. '1 Phenylmercuric Nitrate 1 :10 000.Directions: Remove ' '''rapper and insert one suppository morning and night

and after each bowel movement. Rectal Conditions are more rapid1y improvedby continual application. In case of bleeding, a physician should be consulted.

PAR. 3. Respondent American Home Products Corporationcauses the said preparations , when sold , to be transported from


Complaint 70 F.

its places of business located at 1000 South Grand Street, Ham-monton , :!ew Jersey and 1919 Superior Street, Elkhart , Indianato purchasers thereof located in various other States of the

United States and in the District of Columbia. Respondent main-tains , and at all times mentioned herein has maintained , a courseof trade in said preparations in commerce , as "commerce" is de-fined in the Federal Trade Commission Act. The volume of busi-ness in such commerce has been and is substantial.

PAR. 4. In the course and conduct of its said business , respond-ent has dissenlinated, and caused the dissemination of, cretain

advertisements concerning the said preparations by the United

States mails and by various means in commerce , as "commerce" isdefined in the Federal Trade Commission Act, including, but notlimited to , advertisements inserted in newspapers , magazines andother advertising media , and by means of television and radiobroadcasts transmitted by television and radio stations located inthe District of Columbia and in the various States of the UnitedStates , having suffcient power to carry such broadcasts acrossState lines , for the purpose of inducing and which were likely toinduce , directly or indirectly, the purchase of said preparations;and has disseminated , and caused the dissemination of , advertise-ments concerning said preparations by various means , includingbut not limited to the aforesaid media for the purpose of inducingand which were likely to induce , directly or indirectly, the pur-ehase of said preparations in commerce , as "commerce" is definedin the Federal Trade Commission Act.

PAR. 5. Among and typical of the statements and representa-tions contained in said advertisements disseminated as herein-

above set forth are the following:Radio Commercial

Hemorrhoid sufferers.

. .

the proof is here! Proof of dramatic new reliefof swollen injured tiRSUC! Proof from doctors.

. .

from clinics.

. .

from hos-pitals.

Yes , doctors report a new healing medication.

. .

Preparation H . . . ac-tually shrinks hemorrhoids without surgery. Tests in famous hospitals andclinics reveal: Preparation H relieves pain promptly-heals injured tissue.The secret? Only Preparation H has the new wonder substance that we callBio-Dyne to draw the body s own healing- oxygen to the painful area. Here

are the dramatic results: one-Preparation H relieves pain and itchingpromptly. Two-Preparation H heals injured tissue. And three-PreparationH shrinks hemorrhoids.

. .

without astringents , narcotics , or surgery.

. .

even in cases of twenty years ' suffering. Yes , the proof is here-proof of theprompt relief of painful hemorrhoids. Get clinically tested , hospital tested

1527

1524

AMERICAN HOME PRODUCTS CORP.

Complaint

Preparation H (optional: Ointment or Suppositories). Preparation H . . shrinks hemorrhoids without surgery!

TV CommercialVIDEO

OPEN MS MAN SEATED ATDESK. HE REACHES FORBOOK FROM BOOK-SHELF BE-HIND HIM.

OPEKS BOOK TOWARD AUDI-ENCE , RESTS IT VERTICALLYON DESK BEFORE HIM.

CUT TO OPEN BOOK. SEECHAPTER TITLE: " SHRINKSHEMORRHOIDS WIT H 0 U SURGERY.

PKG. OF PREPARATION HMOVES FORWARD OUT OFTEXT TO MAXIMUM WIDTHSO PRODUCT NAME, CHAP.TER HEADLINE BOTH ARELEGIBLE.

CUT BACK TO MAN. HE RE.FERS TO BOOK.

PAN AS MAN TURNS TO HISRIGHT. TAKES PIPETTE OUTOF RACK, HOLDS IT UP OVEREMPTY TEST-TUBE.

CUT TO ECU GLISTENINGDROP HANGING FROM PIP.ETTE. SUPER TITLE: "BIO.DYNE" AT BOTTOM SCREEN.

AUDIOANNCR. , DIRECT:These are doctors' reports onhemorrhoids. . . revealing a newmedication that relieves pain and

itching promptly, heals injured tis-sue. . .

ANKCR. , OVER.. . . and actually shrinks

rhoids without surgery.

hemor-

It' s the new medical discovery,Preparation H. Clinically tested,hospital tested Preparation

AN"-CR., DIRECT:Yes , hospital tests and clinical testsnow show prompt relief of pain. . .healing and shrinking of swa1len

injured tissue.

The secret? Only Preparation Hcontains Bio-Dyne . . .

ANNCR. , OVER:. . . the remarkable substance thatdra ws the body s own healing oxy-gen to the painful area.

CaT Cards

CLINICAL TESTS SHOW PREPARATION H SHRINKS HEMOR.RHOIDS WITHOUT SURGERY. RELIEVES PAIN-STOPS ITCHINGSHRINKS PILES.

PeTiodical A dveTtisingScience Shrinks Pile New Way \Vithout Surgery Stops Itch Relieves

Pain.


Complaint 70 F. T.

Preparation H- The Only Hemorrhoidal Remedy In Vlorld That ContainsNew Healing Substance.

For the first time science has found a new healing substance with the as-tonishing ability to shrink hemorrhoids, stop burning rectal itch and relievepain-without surgery or painful injections.

Pain and itching were promptly relieved. And while gently relieving thisdistress-actual reduction (shrinking) of hemorrhoids took place.

In fact, results \verc so thorough that sufferers \vere able to make such as-tounding statements as " Piles have ceased to be a problem!" And amongthese sufferers were a wide variety of hemorrhoid conditions some of 10 to 20years ' standing.

An this was accomplished at home without surgery, injections , narcotics orastringents of any kind.

This new healing substance is offered in ointment or convenient supposi-tory form called Preparation H. And Preparation H is the only hemorrhoidalremedy in the world containing this truly magical healing substance.

0; * * full of a new substance which has the astonishing power to heal in-jured skin. This substance was then scientifically combined with other effec-tive medical ingredients into a product called Preparation H. And here s whythis remarkable hemorrhoid remedy is so successful-Preparation Hpromptly relieves pain and burning rectal itch. Shrinks hemorrhoids withoutsurgery. Heals injured tissue baek to norma1 0; * *

PAR. 6. Through the use of said advertisements, and others

similar thereto not specificany set out herein , respondent has rep-resented and is now representing, directly and by implication thatthe use of Preparation H Ointment and Suppositories , and each ofthem , wi1 :

1. Reduce or shrink piles;2. A void the need for surgery as a treatment for piles;

3. Eliminate an itch due to or ascribed to piles;4. Relieve an pain attributed to or caused by piles;

5. Heal , cure or remove piles , and cause piJes to cease to be aproblem.

PAR. 7. In truth and in fact the use of Preparation H Ointmentor Suppositories , or both , wi1 not:

1. Reduce or shrink piles;2. A void the need for surgery as a treatment for piles;3. Eliminate an itch due to or ascribed to piles;4. Relieve an pain attributed to or caused by piles;

5. Heal , cure or remove piles or eliminate the problem of piles;6. Afford any relief or have any therapeutic effect upon the

eonditions known as piles or upon any of the symptoms or mani-festations thereof in excess of affording temporary relief of minorpain or minor itching associated with piles.

Therefore , the advertisements referred to in Paragraph Five

AMERICAN HOME PRODGcTS CORP. 1529

1524 Initial Decision

were and are misleading in material respects and constituted andnow constitute

, "

false advertisements " as that term is defined inthe Federal Trade Commission Act.

PAR. 8. The dissemination by the respondent of the false adver-tisements , as aforesaid, constituted, and now constitutes , unfairand deceptive acts and practices in commerce, in violation of sec-

tions 5 and 12 of the Federal Trade Commission Act.

Mr. Char-les J. Connolly and Mr. William E. McMahon, II forthe Commission.

Donovan, Leisure , Newton Irvine New York, N. , attorneysfor respondent.

Mr. Samuel W. J\Jurphy, h. , Mr. Kenneth N. Hart and M1"James 1.11. Be?' gen of counsel.

INITIAL DEcISIOX BY WALTER R. JOHNSON , HEARING EXA~!INER

OCTOBER 22 , 1965

By complaint dated August 28, 1964, the respondent has beencharged with violation of Sections 5' and 12' of the FederalTrade Commission Act in its advertising of Preparation H oint-ment and suppositories used for the treatment of a conditionknown as piles or hemonhoids. The respondent filed its answer tothe complaint on October 16 , 1964, denying the charges of decep-

tive advertising and stating that the Commission has previouslyapproved the advertising al1eged in the complaint to be unlawfuland that respondent has conducted its activities in reJiance there-on. On Kovember 9, 1964 , counsel for the parties met with thehearing examiner in a reported pre-hearing conference , and anorder was issued reciting the results of the conference , which wasto control the subsequent course of the proceeding, unless modi-

fied to prevent manifest inj ustice. The order, among other thingsrequired each party to file a pre-trial brief setting forth a state-ment of anticipated issues and divulging the names of the

1 " Sec. 5(a) (1) Unfair methods of com!Jetition in eOmrnL' 1'Ce, and unfair or d"c ptivc acts

or practices in commerce , are hereby lleclared unlawful. '" '" '" ,

, "

Sec. 1 (a) It snalJ be unlawful fol' nny jJerson , jJartnershiil , or corporation to di seminf1te.OJ' cause to be di seminated. any false adYertisement

(1) By United States mails, OJ' in commerce oy any means, for the purpose of inducing, orwhich is likely to induce , directly OJ' illdirectly the 11Ul'chase of food, drugs , devices, or cosmetics;

.. (2) By any means , foJ' the pUl'pO c of inducing', or which is likely to induce, directly, orindirectJy, th.. purchase in commerce of food , drugs, devices , or cosmetics.

(b) The dissemination or the causing to be disseminated of any false advertisement within

the provisions of subsection (a) of this section shall be an unfaiJ' oj' deceptive act or practicein commerce within the meaning- of section


Initia1 Decision 70 F.

witnesses and the documentary exhibits which the party plans tointroduce. The order further provided that a party may notintroduce any testimony or exhibits which have not been referredto in the trial brief. Trial briefs were filed by complaint counseland respondent on December 11 , 1964 , and January 18, 1965, re-

spectively. At a conference held on January 29 , 1965 , the subjectof time and place of hearings was discussed , and , on the basis ofinformation supplied by counsel for the parties , the hearing exam-iner scheduled hearings herein. In support of the compJaint , hear-ings were held at New York , N. , on March 30 , 31 , and Aprij 11965; at Philadelphia , Pa. , on April 7 and 8 , 1965; at PittsburghPa. , on April 12 and 13, 1965; and at Chicago , I1inois , on April15 and 16, 1965. The respondent put in its defense from April20 through May 6, 1965 (13 days) at Washington, D.Complaint counse1 submitted rebuttal testimony at Washington

, on May 17 and 18 , 1965. Testimony was received from atotal of 35 witnesses , 11 being ca1Jed by complaint counsel , and 26by respondent. The record includes 2139 pages of transcript and

54 exhibits , totaling more than 900 sheets. On July 19 , 1965 , theparties filed proposed findings , and on August 20 , 1965 filed re-plies thereto. The hearing examiner heard oral arguments there-on on September 14, 1965. The fo1Jowing abbreviations havebeen used herein: " " for Commission s Complaint; " " for

Respondent' s Answer; "Par." for Paragraph; "Tr." for Tran-script of Proceedings; "cx" for Commission Exhibit; !lRX" forRespondent' s Exhibit; "CPF" for Complaint Counse1's ProposedFindings; and "RPF" for Respondent' s Proposed Findings. Theproposed findings of fact and conclusions not hereinafter specifi-ca1Jy found or concluded are herewith rejected. L;pon considera-

tion of the entire record herein , the hearing examiner makes thefollowing findings of fact and conclusions:

Respondent American Home Products Corporation is a corpora-tion organized , existing and doing business under and by virtue ofthe laws of the State of Delaware with its principal offce andplace of business located at 685 Third Avenue in the city of NewYork , State of New York (C. , Par. 1; A. , Par. 1).

Respondent American Home Products Corporation is now , andfor more than one year last past has been , engaged in the sale anddistribution of preparations offered for the treatment of piles orhemorrhoids and coming within the classification of drugs as theterm "drug" is defmed in the Federal Trade Commission Act (C.Par. 2; A. , Par. 2).



The designations used by respondent for said preparations , theformulae" thereof and directions for use are as follows:

(1) Designation: " Preparation H" 01ntment.

Formula: The active ingredients for Preparation H Ointment are asfollows:

Live Yeast Cell Derivative , Supplying 2 000 units, Skin RespiratoryFactor (Bio Dyne) Per Ounce of Ointment; Shark Liver Oil 3.0%;Phenylmercuric Nitrate 1:10 000 in a base composed of petrolatum , lano-lin , faIba , mineral oil and oil of thyme.

Directions: Remove new protective cover. Apply freely night andmorning and after each bowel movement. Lubricate applicator beforeeach application and thoroughly cleanse after use. Rectal conditions aremore rapidly improved by continual application.

CA UTION: In case of bleeding, a physician should be consulted. Keep allmedicines out of the reach of children.

(2) Designation: " Preparation II" Suppositories.

Formula: The active ingredients are Live Yeast Cell Derivativesupplying 2 000 units , Skin Respiratory Factor (Rio Dyne) Per Ounce ofSuppository Base; Shark Liver Oil 3.0% Phenylmercurk Nitrate1 :10,000 in a base made up of cocoa butter , beeswax , polyethylene glycol600 dilaurate , and glycerin.

Directions: Remove wrapper and insert one suppository morning andnight and after each bowel movement. Rectal conditions are more rapidlyimproved by continual application.

CA UTION: In case of bleeding, a physician should be consulted.

(C. , Par. 2; A. , Par. 2; CX 5-8; RX 9- 10; Stipulation , Tr. 68; Tr.1017-19.

Respondent American Home Products Corporation causes theeaid preparations , when sold , to be transported from its places ofbusiness located at 1000 South Grand Street , Hammonton , NewJersey, and 1919 Superior Street , Elkhart, Indiana , to purchasersthereof located in various other States of the United States and inthe District of Columbia. Respondent maintains , and at all timesmentioned herein has maintained , a course of trade in said pre-parations in commerce , as "commerce" is defined in the FederalTrade Commission Act. The volume of business in such commercehas been and is substantial (C., Par. 3; A. , Par. 3).

In the course and conduct of its said business , respondent hasdisseminated , and caused the dissemination of, certain advertise-ments conceming the said preparations by the United Statesmails and by various means in commerce, as "commerce" is de-fined in the Federal Trade Commission Act, including, but notJimited to , advertisements inserted in newspapers , magazines , and

'The Quantitative formu1a.e for Preparation Hareevidence as in camera exhibits (CX 7. 8: Tr. 92- 93. 97).

trade secrets and were received in


Initial Decision 70 F.

other advertising media , and by means of television and radiobroadcasts transmitted by television and radio stations located inthe District of Columbia and in various States of the UnitedStates , having suffcient power to carry such broadcasts acrossState Jines , for the purpose of inducing and which were likely toinduce , directly or indirectly, the purchase of said preparations;and has disseminated , and caused the dissemination of , advertise-ments concerning said preparations by various means , including,but not limited to , the aforesaid media for the purpose of induc-ing and which were likely to induce , directly or indirectly, the pur-chase of said preparations in commerce, as Hcommerce" is definedin the Federal Trade Commission Act (C. , Par. 4; A. , Par. 4).

Among and typical of the statements and representations con-tained in the advertisements disseminated as set forth in the fore-going paragraph are the fol1owing:

Radio CommericiaZ

Hemorrhoid sufferers. .of swollen injured tissue!hospitals.

. the proof is here! Proof of dramatic new reliefProof from doctors. . from clinics.. from

Yes , doctors report a TIe\v healjng medication. . Preparation H . . . actually shrinks hemorrhoids without surgery. Tests in famous hospitals andclinics reveal: Preparation H relieves pain promptly-heals injured tissue.The secret? Only Preparation H has the new wonder substance that we callBio-Dyne to draw the body s o\vn healing oxygen to the painful area. Here

are the dramatic resuJts: One-Preparation H relieves pain and itchingpromptly. Two-Preparation H heals injured tissue. And three-PreparationH shrinks hemorrhoids. . . without astringents, narcotics , or surgery. . .even in cases of twenty years ' suffering. Yes , the proof is here-proof of theprompt relief of painful hemorrhoids. Get clinically tested , hospital tested

Preparation H (optional: Ointment or Suppositories). Preparation H . . .shrinks hemorrhoids without surgery!

TV Commercial

VIDEOOPEN MS MA SEATED ATDESK. HE REACHES FORBOOK FROM BOOK-SHELF BE.HIND HIM.

AUDIOANN CR. , DIRECT:These are doctors' reports onhemorrhoids. . . revealing a newmedication that relieves pain and

itching promptly, heals injured tis-sue.OPENS BOOK TOWARD AUDI.

ENCE , RESTS IT VERTICALLYON DESK BEFORE HIM.

1524


Initial Decision

CUT TO OPEN BOOK. SEECHAPTER TITLE: " SHRINKSHE~!ORRHOIDS WIT H OUTSURGERY.

PKG. OF PREPARATION HMOVES FORWARD OUT OFTEXT TO MAXIMUM WIDTHSO PRODUCT NAME, CHAP.TER HEADLINE BOTH ARELEGIBLE.

CUT BACK TO MAN. HE RE-FERS TO BOOK.

PAN AS MAN TURNS TO HISRIGHT. TAKES PIPETTE OUTOF RACK, HOLDS IT UP OVERE~IPTY TEST.TUBE.

CUT TO ECU GLISTENINGDROP HANGING FRO:v PIP.ETTE. SUPER TITLE: "BIO.DYXE" AT BOTTOM SCREEN.

ANNCR., OVER. . . and actually shrinks

rhoids without surgery.

hemor

It' s the new medical discovery,Preparation H. Clinically testedhospital tested Preparation H.

ANNCR., DIRECT:Yes , haspi tal tests and clinicaltests now show prompt relief ofpain. . . healing and shrinking of

swollen, injured tissue.

The secret? Only Preparation Hcontains Bio-Dyne . . ,

ANNCR. , OVER:. . . the remarkable substance thatdraws the body s own healing oxy-gen to the painful area.

Cnr CnrdsCLINICAL TESTS SHOW PREPARATION H SHRINKS HEMOR.

RHOIDS WITHOUT SURGERY. RELIEVES PAIN-STOPS ITCHINGSHRINKS PILES.

Periodical AdvertisingSCIENCE SHRINKS PILES NEW WAY WITHOUT SURGERY STOPS

ITCH-RELIEVES PAI:-Preparation H- The Only Hemorrhoidal Remedy In World That Containsew Healing Substance.Every Claim Verified by Doctors and Proved By 4 Leading Clinics.For the first time science has found a new healing substance with the as-

tonishing abilty to shrink hemorrhoids, stop burning rectal itch and relieve

pain-without surgery or painful injections.In one hemorrhoid case after another prompt relief was reported-also a

striking improvement" in from 2 to 4 days. These reports were verified by adoctor s observations and proved by four leading c1inics.

Pain and itching were promptly relieved. And while gently relieving thisdistress-actual reduction (shrinking) of hemorrhoids took place. Most ama-ing of all- this improvement was maintained in cases where a doctor s obser-

vations ,vere continued over a period of many months

In fact , results were so thorough that sufferers were able to make such as-



tounding statements as "Piles have ceased to be a problem!" And amongthese sufferers were a wide variety of hemorrhoid conditions some of 10 to 20years ' standing.

All this \vas accomplished at home without surgery, injections , narcotics orastringents of any kind. The secret is a new healing substance (Bio-Dyne)-the discovery of a world famous research institute. This new healing sub-stance is offered in ointment or convenient suppository form called Prepara-tion H. And Preparation H is the only hemorrhoidal remedy in the world con-taining this truly magical healing substance.

Magic Heahng PowerDiscovered by Accident

Like many great discoveries-the effectiveness of Preparation II was alsodiscovered quite by accident. In the laboratories of a famous research institution in Cincinnati , Ohio-rcno\'med scientists were conducting advanced med-ica1 tests.

During an ether-extracting procedure , there was a sudden explosion. A n as-sistant \vas severely burned. As an emergency measure , large quantities ofan ointment (stil1 in an experimental stage) were smeared on. To everyoneamazement-pain ceased immediately and the skin healed remarkably fastwithout scarring.

Later tests revealed this ointment '\vas full of a new substance which hasthe astonishing power to heal injured skin. This substance was then scientifi-cally combined with other effective medical ingredients into a product caUed

Preparation H. And here s why this remarkable hemorrhoid remedy is so suc-cessful-Preparation H promptly relieves pain and burning rectal itch.Shrinks hemorrhoids without surgery. Heals injured tissue back to normal

and helps prevent infection of hemorrhoids.Every claim made for Preparation H has been verified by doctors. This is

the only hemorrhoidal remedy containing Bio-Dyne. Just ask for PreparationH at any drug counter in ointment or suppository form.

(CX 9-14; RX 21 , 22; Tr. 1917.

Paragraph Six of the complaint aJleges that , through the use ofsaid advertisements , respondent has represented , directly and byimplication , that the use of Preparation H Ointment and Supposi-tories wiJl:

1. Reduce or shrink piles;2. A void the need for surgery as a treatment for piJes;3. Eliminate aJl itch due to or ascribed to piles;4. Relieve aJl pain attributed to or caused by piles;

5. Heal , cure or remove piles, and cause piles to cease to be aproblem.

Paragraph Seven of the complaint aJleges that in truth and infact the use of said preparations wil not;

1. Reduce or shrink piJes;2. A void the need for surgery as a treatment for piJes;3. EJiminate aJl itch due to or ascribed to piJes;



4. Relieve all pain attributed to or caused by piles;

5. Heal , cure or remove piles or eliminate the problem of piles;6. Afford any relief or have any therapeutic effect upon the

conditions known as piles or upon any of the symptoms or mani-festations thereof in excess of affording temporary relief of minorpain or minor itching associated with piles.

The respondent denies the aDegations in Paragraph Six of the

complaint , except that it admits it has represented the use of itspreparations wil:

a. reduce or shrink hemorrhoids without surgery;b. stop itching due to hemorrhoids; andc. relieve pain due to hemorrhoids (A. , Par. 6).Respondent denies the allegations of Paragraph Seven of the

complaint (A. , Par. 7), and takes the position that the advertis-ing, properly interpreted , is truthful in every respect.Complaint counsel did not call any public or consumer wit-

nesses to support their interpretation of the advertising and rely

solely on the advertisements themselves.' As to aDeged lack ofeffcacy of the preparations involved , complaint counsel rely onthe testimony of nine proctologists caDed as witnesses in supportof the complaint. The respondent presented six medical witnesseswho had conducted clinical studies of Preparation H , and fiveother doctors who testified as to conservative therapy and the ef-fectiveness of ointments and suppositories in general in the treat-ment of hemorrhoids; testimony relating to the pharmacology ofthe product; and seven consumer witnesses , who testified on theimpression respondent's advertisements made on them and on therelief they had obtained from the use of Preparation H.

The governing law, which is applicable in this proceeding, can

be weD stated by employing the words of the Court in C.

SteTling Drug, Inc. , et al. 317 F. 2d 669 , 674 (C. A. 2 , 1963), read-ing:

The legal principles to be applied here are quite clear. The central purposeof the provisions of the Federal Trade Commission Act under discussion is ineffect to abolish the l'ule of ca' veat emptm' which traditionally defined rights

'In thQ oj,inion of the Commission in Docket No. 8.'i86 (July 31, 1964), In the Matter ofUnited Statcs R!!b/JCT Company, it is stated 66 F. C 38i, 397J:It is weJl settled that the Commission is not required to sample public opinion in order to

dett=l"mine the meaning convey d by an RdvE'l'tiscment. Royal Oil C01'porution v. 262 F.2d 741 (lg59): ,Ve11 American LibrarJj of World Literature v. C., 213 F. 2d 143 (1%4). InhDJding that the Commissior. was no: reQuil' ed to call C()fJSlHTH'r witnesses the court in ZenithRadio Corporation v. C. 1143 F. 2d 29 (1944)j stated ' The Commission has a right to lookat the advertisements in question , consider the relevant evidence in the recol'd that would aidit in jr.terp!"eting the advertisements, and then decide fol' itself whether the practices engagedin by the petitione!" were unfair or deceptive, as charged in the complaint.

' ..



and responsibilities in the '\vorld of commerce. That rule can no longer be rc-lied upon as a means of rewarding fraud and deception Federal TTade CO?n-mi,:;sion v. Standard Education Society, 302 lJ. S. 112, 116, 58 S.Ct. 113, 82L.Ed. 141 (1937), and has been replaced by a yule "\vhich gives to the con-sumer the right to rely upon representations of facts as the truth Goodmanv. Federal Trad-; COJnl1t1 ssion 244 F. 2d 584 , 603 (9th Gir. , 1957). In orderbest to implemcnt the prophylactic purpose of the statute , it has been consist-ently held that advertising falls within its proscription not only when there isproof of actual deception but also when the representations made have a ca-pacity or tendency to deceive wJl€n there is a likelihood or fair probabil-

ity that the reader wil1 be misl'2d. See Amen can Life Accid. Ins. Co.

Federal Trade Comm,issiou 255 F. 2d 289, 293 (8th Cir.) , cert. denied 35RS. 875 , 79 S. Ct. 115 , 3 L.Ed. 2d 105 (l958); Cha1'es of Ow Ritz Distrlbut01'

Corp. v. Fede? al Tmde Commission 143 F. 2d 676 , 680 (2d Cir. , 1944); Herz-feld v. Federal Tmde Commission 140 F. 2d 207 (2d Cir., 1944). For thesame reason , proof of intention to deceive is not r.:oquisite to a finding of vio-lation of the statute mbel Bros. , Inc. v. Frderal Trade Commission 116 F.2d 578 (2d Cir. , 1941); since the purpose of the statute is not to punish the"\vrongdoer but to protect the public , the cardinal factor is the probable effect

\vhich the advertisE'r s handiwork \viJ have upon the eye and mind of thereader. It is therefore necessary in these cases to consider the advertisementin its entirety and not to engRg'e in disputatious dissection. The entire mosaicshould be viewed rather than each tile separately. iTJhe buying publicdoes not ordinariJy carefully stndy or weigh each word in an advertisement.The ultimate impression upon the mind of the reader arises from the sumtotal of not only what is said but also of all that is reasonably implied.

ATonberg v. Fedwral Trade Commission 132 F. 2d 165, 167 (7th Cir. 1912).

Respondent' s Advertising Claims fOT PTepamtion H. The radiocommercial (CX 9) asserts that:

Yes, doctors report a new healing medication. . . Preparation II . . . actuallyshrinks hemorrhoids without surgery. " " * Here are the dramatic results:one- Preparation H relieves pain and itching promptly. Two-PreparationH heals injured tissue. And three-Preparation II shrinks hemorrhoidswithout astringents, narcotics , or surgery. ..

"" *

Preparation Hshrinks hemorrhoids without surgery!

In the television commercial (CX 10) , it is said:

These are doctors ' reports on hemorrhoids. . . revealing a new medicationthat relieves pain and itching promptly, heals injured tissue. ,

. . . and actually shrinks hemorrhoids "\vithout surgery.

It' s the ncw medical discovery, Preparation H.

The car cards (CX 11) displayed on subways and buses state:

Clinical Tests Show PREPARATION H SHRINKS HEMORRHOIDSWITHoeT SURGERY Relieves Pain- Stops Itching Shrinks Pilcs



A typical and representative periodical advertisement (CX 12)claims:

SCIENCE SHRINKS PILES NEW WAY WITHOUT SURGERY STOPSITCH-RELIEVES PAIN

For the first time science has found a new healing substance with the as-tonishing ability to shrink hemorrhoids, stop burning recta! itch and relievepain-without surgery or painful injections.

In fact , results \vere so thorough that sufferers \vere able to make such as-tounding statements as " Piles have ceased to be a problem!"

Prepf!ration H promptly relieves pain and burning rectal itch. Shrinks hemorrhoids without surgery. Heals injured tissue back to normal. . . .

A newspaper advertisement (CX 13) reads:

A .world-famous institute has discovered a new substance \vhich has the as-tonishing ability to shrink hemorrhoids without surgery.

Only Preparation H contains this magic new substance which quickly helpshea1 injured cells back to normal and stimulates regrowth of health tissueagain.

A typical advertisement (CX 14; RX 21) reads:

For the first time science has found a new healing substance. . . .Most amazing of all-results were so thorough that sufferers made aston-

ishing statements like ' Piles have ceased to be a problem!"The secret is a new healing substance (Bio-Dyne)-discovery of a world-

famous research institute.

Seven consumer witnesses testified about the messages whichwere conveyed to them by the advertising now under attack.These witnesses testified that, on seeing or hearing the advertis-ing, they had received the impression that Preparation H win re-lieve hemorrhoidal symptoms:

(J) Vincent: To me , it just struck me that it wou1d Te1ieve it , not as acure-all (1'1'. 1815).

(2) Garth: I got the message that they would.relief and stop the itching and pain. . . ." (Tr. 1837).

(3) PoltTek: relief from pain and itching, and reducing swellng(Tr. 1851).

(4) Clancey: That it would bring relief to me " (1'1'. 1863).(5) Valenthw: I thought it would get me over a bad time" (Tr. 1875).

(6) Rollins: . . . that the only claim made by Preparation H was itgives reJief" (Tr. 1887).

(7) Jones: Well , that it would give me some relief" (Tr. 1902).

give me immediate



A1l seven of these witnesses testified to the effect that the ad-vertisements did not give the impression that Preparation H

wouJd cure hemorrhoids (Vincent, Tr. 1817; Garth, Tr. 1838;Poltrek, Tr. 1851-52; Clancey, Tr. 1863; Valentine, Tr. 1875;Ro1lns, Tr. 1887; Jones, Tr. 1902). When the attention of thewitnesses was specifica1ly focused on respondent' s car ad (CX11) reading "Clinical Tests Show PREPARATIOK H SHRINKSHEMORRHOIDS WITHOUT SVRGERY . . . ," the answers ofthree of the witnesses are significant:

Vincent: To me , it means it' s going to give IDe relief and prevent my hav-ing to be operated on or help me. . . . (Tr. 1816.

Ga?"th: As I look now, it does shrink the hemorrhoids withoutsurgery.. . (Tr. 1840.

Poltrek: WeU, I think anyone \vauld try something without surgery, andthis certainly would hit the public eye. . . . Do I understand you correctly,sir , YOll mean without surgery? This is the OTIe thing I would say. No one isgoing to have surgical procedure if they don t need to have it. If they do , it

would be something else. But in this case you don t. .. (Tr. 1852.

All of respondent's advertisements received in evidence cJaim,

in substance , that Preparation H wil shrink hemorrhoids with-out surgery (CX 9-14; RX 21 , 22). It is the opinion of the hear-ing examiner that respondent has represented in its advertising,as has been alleged in the compJaint (Par. Six (2)), that Prepa-ration H wil enable the user to avoid the need for surgery wheresurgery is required as a treatment for hemorrhoids. It is also thehearing examiner s opinion that respondent's advertisements do

not claim that Preparation I-I will eliminate all itch or relieve allpain as has been alJeged in paragraphs Six (3) and Six (4) of thecomplaint. The word "al1" is never used in any of the advertise-ments to describe the relief to be afforded by the product fromitch or pain. The word "alJ" is that of complaint counsel and notrespondent." It is further the opinion of the hearing examiner

'In InternatiDnal Pa.rts Corp. v. Federal Trade Commission 133 F. 2.d 883 (7th CiT. 3), the

Court deal': with a similar jJl'oblem:In Parag-raph of the Commjs ion s ord",r, the petitioner is ordered to cease and desi8t

from repre enting that the finish on its rnufTers 1)crmanenti'f prevents ru t or corrosion. The

petitioner never represented that the finish on its muffers would prevent rust )JcTlllancntly.The word l)crmanently WCl interpolated by the Commission. The Commbsion s ii.nding i$ that\VhUe the finish may erve to j)ren:'nt rust and corrosion for "- limited period of time, it (loes

not allonl permanent l)rotection against such conditioIls.' (Our i7th Circuit' s:! emphas:s. ) Thepetitioner never said that it did (lITora )1ermar,ent j)wtection against such conditions. The

petitioner said only that the finish prevents ru t and corrosion. . " , The Commission canninterpoJate into the petitione'" s representations words not there, and then find the petitionerguiJty uf rniHPJ))'esentation because the petitioner s product does nut meet the Commissionrevised representations.

, ,

\Vithout the word ' permanently ' interpolated , there is no ,-is-representation. The word ' permanent ' is the Commission s word , nul the petitioner

(133 F, 2d 885-86.



that with use of such expressions as "Most amazing of all-re-sults were so thorough that sufferers made astonishing state-ments like ' Piles have ceased to be a problem

!' " ; "

The secret is anew healing substance (Bio-Dyne)" CX 14; RX 21); and "Healsinjured tissue back to normal. . . ." (CX 12), respondent hasrepresented , as charged in paragraph SIX (5) of the complaintthat Preparation H will uReal , cure or remove piles, and cause

piJes to cease to be a problem." It is found that through the use ofsaid advertisements , and other similar thereto not specifically setout herein , respondent has represented and is now representing,directly and by implication , that the use of Preparation H Oint-ment and Suppositories , and each of them , wil:

1. Reduce or shrink piles;2. Avoid the need for surgery as a treatment for piles;3. Stop itch due to piles;4. Relieve pain due to piles;5. Heal , cure or remove piles, and cause piles to cease to be a

pro bJem.

The nine physicians called by complaint counsel in connection

with their case-in-chief were Dr. Richard A. Hopping, East Or-ange , Kew Jersey (Tr. 102-182); Dr. A. W. Martin Marino , Jr.Brooklyn , New York (Tr. 185-245) ; Dr . Sylvan D. Manheim , NewYork (Tr. 247-329) ; Dr. Samuel W. Eisenberg, Philadelphia , Pa.(Tr. 335-406); Dr. Joseph B. Sarner, Philadelphia, Fa. (Tr.409- 470); Dr. Andrew Jack McAdams, Pittsburgh, Pa. (Tr.474-528) ; Dr. KarJ Zimmerman , Pittsburgh , Pa. (Tr. 536-597) ;Dr. Charles Evans Pope , Evanston , Ill. (Tr. 601-692); and Dr.Durand Smith, Chicago , Ill. (Tr. 695-794). Each specializes inproctology, which deals with diseases affecting the anus , rectumand lower coJon , including hemorrhoids. They are members of , andcertified by, the American Board of Colon & Rectal Surgery, anexclusive group of less than 500 surgeons.

The medical witnesses called by respondent were Dr. FrederickSteigmann , Chicago, 111. , a specialist in internal medicine andgastroenterology (Tr. 808-834);; ; Dr. Fred J. Phillips , Quaker-town , Pa. , a general practitioner (Tr. 835-860) ; Dr. Russel JohnSacco, Kinnelon. Kew Jersey, a general practitioner (Tr.864-885) ; Dr. Harold S. Feldman, Livingstone , )! ew Jersey, ageneral practitioner (Tr. 887-926); Dr. Donald Berkowitz , Phila-

6 Dr. Steig:mann explained that p,'astrOo.nterology " is more of a medical pecialty while proc-

tology deals more with surgical principles. " Both specialties deal generally with the samejJRrts of the anatomy (Tr. !HO).



delphia, Pa., a gastroenteroJogist (Tr. 1075-1218) ; Dr. WilliamLieberman , Brooklyn , !'ew York , a proctologist (Tr. 1219-1419) ;Dr. Robert Young, Columbus, Ohio, a general surgeon (Tr.1441-1512) ; Dr. Orum Philip Burt, Columbus , Ohio , an obstetri-cian and gynecologist (Tr. 1514-1546); Dr. Jerome EpsteinWashington , D. , a speciaJist in internal medicine and gastroen-terology (Tr. 1549-1650); Dr. Korman Isaacson, Washington

, a general surgeon (Tr. 1651-1682) ; and Dr. Arthur Groll-man , Dallas , Texas , a consulting physician and an authority onpharmacology (Tr. 1750-1797).

Hemorrhoids , aJso called piles , are varicose (dilated) veins inand around the rectal opening. They are classified as internal , ex-ternal , and mixed, based upon the location of the hemorrhoidal

veins in relation to the sphincter , the ringlike muscle that sur-rounds the opening to the rectum. Internal hemorrhoids originatefrom veins above the sphincter , and are covered \vith a mucousmembrane , while externaJ hemorrhoids arise from veins outsidethe sphincter , and are covered by skin. Mixed hemorrhoids are acombination of internaJ and external hemorrhoids. Hemorrhoidsare common among the adult population , and estimates of its inci-dence range upwards from fifty percent. There is a tendency forvaricose veins to run in families. Hemorrhoids are quite commonduring pregnancy as a result of increased pressure of the enlarg-ing abdomen and uterus , which tends to overdistend these veins.In and of themseJves , such hemorrhoidal varicosities are not trou-blesome , and many people have asymptomatic hemorrhoids (caus-ing no symptoms) without being aware of the fact. Asymptomatichemorrhoids are harmJess and do not require treatment. Such a

condition , however , may become symptomatic from time to timeas a result of one or more exciting- or complicating factors , suchas constipation , diarrhea , straining, trauma , infection, or condi-

tions or activities which increase pressure on the hemorrhoidalveins. In medical terminology, "symptoms" are subjective com-plaints given by the patient, while "signs" are objective signalswhich can be seen and felt by the examining physician. To the pa-tient , the symptoms are the essence of the disease. He feels pain.To make a diagnosis , the doctor pieces together the history andsymptoms reported to him with the signs of the disease he sees.The most usual hemorrhoidal symptoms include one or mOre ofbleeding, pain , protrusion, sweJJing, discharge , itching, and asense of discomfort or fuJJness at the anus. The signs of hemor-rhoids inc1ude protrusion , sweJJing, bJeeding, and discoloration of



the area involved. These symptoms vary in degree from mild tosevere , and symptomatic hemorrhoids are frequently very painfulirritating, and troublesome. The mucosal and skin- like tissue sur-rounding the varicose veins is integrally involved in a sympto-

matic hemorrhoidal conditions. Symptoms are usually caused-complications , such as inflammation , edema , ulceration , or infec-

tion , in the adjacent tissue, rather than by the mere existence ofvaricose veins. (This finding is based on CPF Nos. , 10, 11 , 12

, 14 and 18; RPF Nos. 8, 9 , 10 and 11; and the citations of re-cord set forth therein.

The opinion testimony of each of the nine proctologists calledas witnesses by complaint counsel was that the only treatment

which would effect a cure of hemorrhoids was surgery. The basisfor such an opinion is that a hemorrhoid is a vascular dilationand, until that vascular dilation is eliminated, the hemorrhoidwill remain (Hopping, Tr. 118; Marino, Tr. 195, 200 , 201 , 208;

Manheim, Tr. 262; Eisenberg, Tr. 352-53; Sarner, Tr. 422-23;McAdams, Tr, 487; Zimmerman, Tr. 550; Pope, Tr. 616; andSmith , Tr. 719-720). For instance , Dr. :V1arino said (Tr. 213) :

Unless the venous dilatation is eliminated the piles or hemorrhoids wil not becured.

In a hemorrhoidal problem , the supporting and covering tissuesare involved , as well as the varicose veins:Dr. Hopping:

Q. Leaving Qut of consideration the secondary manifestations , \vhat prob-lem does the hemorrhoid itself cause the patient?

A. That is why we call them asymptomatic. Absolutely none (Tr. 181).Dr. Marino:

Q. Isn t it true that many of the symptoms that a patient with hemor-rhoids has , in terms of a direct effect, come from a pathology in the tissuerather than from the vein itself?

A. 1 think that is true, yes (Tr. 235).

Dr. McAdams:Q. Are the supporting: tissues and the covering tissues separate anatomic

entities from the dilated vein?A. Xo. They are separate and distinct microscopically and the hemorrhoids

or dilated veins can be dissected away from the over1ying skin or mucousmembrane , but for practical purposes they are related to the supporting tis-sue , the veins and the covering of them are a unit (Tr. 480).

Q. Now , if this enlargement can be protected against trauma, and if someof the secondary complications to 'which we have referred can be cleared up,may the hemorrhoid be returned to an asymptomatic state?


Initial Decision 70 F. T.

A. Yes (Tr. 509).

A. Yes, but in talking about "hemorrhoids, I don t believe you can separatethe mucosal covering from the underlying varicosity (Tr. 517).

Dr. Zimmerrn:Q. Now, Doctor, where a patient has a hemorrhoidal problem which is

causing him symptoms , there is more involved in that problem than simplythe varicose veins , isn t there?

A. Yes.

Q. The tissue is involved to some extent and the overlying mucosa, isn

that so?

A. Yes.

Q. And his prob1em, his immediate IJToblem is made up of all those things;the veins , the tissue and the mucosa , is that so?

A. Yes (Tr. 571).

Q. Now, Doctor, if you can prevent or clear up infection and prevent orclear up irritation to relieve edema , protect against trauma, may that nothave a beneficial effect on the symptoms which a patient is suffering from hishemorrhoidal prcblems?

A. Yes (Tr. 577).

Dr. Pope:A. The problem of the hemorrhoids to the physician , naturally, involves an

of the tissue , both under the mucous membrane and the overlying portion ex-ternally.

Q. And you are concerned when you are treating a patient for hemorrhoidswith the .whole complex of tissue and vein and mucosa involved in that particular probl'Cm , are you not?A. Yes , very definitely (Tr. 636).

Dr. Smith:

Q. Doctor, in terms of the entire problem of a hemorrhoid , is it correct

that there is involved in addition to the varicose vein or group of varicose

veins the overlying and surrounding tissue?A. Yes , I stated that before , that the components consisted of the covering

plus the varicosity, sir (Tr. 74S-A).

Surgery does not insure that a troublesome hemorrhoid wi1 notrecur:

Dr. Hopping:A. It all depends on who does it and how thorough he is. The recurrence

rate is obviously present in every surgical procedure. But the recurrence ratein good hands of a good hemorrhoidectomy is rather small (Tr. 146).

Dr. Z'immernw.

Q. Were any of those patients , those on which you performeddectomies , people who had had previous hemorrhoidectomies?

A. Yes (Tr. 578).

hemorrhoi-



Q. Are you familiar with the fact Doctoy that Dr. Fansler has estimatedthat there may be unsatisfactory results from hemorrhoidectomies, perhapsin as man;\ as 20 per cent of all cases?

A. I didn t kno\\' the 20 per cent figure (Tr. 581).

Q. . . . could you make an estimate of the percentage of all hemorrhoidec-tomies in which there is apt to be an unsatjsfactory result?

A. I wouldn t like to make a percentage estimate , but I believe that WaIterFansler is probably a little high. But there is certainly an area there whereit is true about the recurrence and trouble afterwards (Tr. 582).

The nine witnesses testified that pallative treatments wereavailable which would not effect a cure, but would relieve thesymptoms. One of the procedures employed by the proctologists inconnection with internal hemorrhoids is the injection treatment,which consists of inj ecting an irritating solution , such as phenolor quinine urea , into the area where the network of veins is situ-ated , causing scar tissue to form which wil compress the veinsinvolved and shrink the hemorrhoidal mass. (Hopping, Tr. 118

144-145; Marino , Tr. 200-201; Manheim , Tr. 262-63; Eisenberg,Tr. 352-53; Sarner , Tr. 422-23; :VIcAdams , Tr. 487-88; Zimmer-man , Tr. 550-52; Pope , Tr. 616-17; and Smith , Tr. 720-21. ) Dr.Marino explained:

As regards injection treatment, you can achieve long palliation , but, ofcourse , the vascular tlssue is sti1 there and frequent.ly people who have beentreated ,,,jth injectional therapy for hemorrhoids wi1 require subsequentinjections as time goes by, so that I don t think you can really speak of cure.You can speak of pal1iation with injections (Tr. 201).

In some instances relief can be achieved by altering the diet toeliminate irritative foodstuffs; using medications to soften thestool; improving the bowel habits; a voiding straining at stool;taking hot Sitz baths (sitting in hot water) ; and using ointmentsand suppositories. (Hopping, Tr. 120- , 136; Marino , Tr. 202;

Manheim, Tr. 306-307; Eisenberg, Tr. 354-360; Sarner, Tr.423-24; McAdams, Tr. 487-88; Zimmerman, Tr. 553-54; PopeTr. 617; and Smith , Tr. 721-23.

The discomforts and symptoms of hemorrhoids frequently sub-side spontaneously (CPF No. 37) :

Dr. Hopping:t\ature and the resources of the body frequently take care of the immedi-

ate acute situation and heal it in the course of time. They don t heal the hemM

orrhoids (Tr. 119).



. Marino:The s\Nelling subsides. Any infection or inflammation that may be present

subsides. Irritative bowel movements may be relieved , and this would effectsome degree of relief of an acute process , an acute hemorrhoidal situation(Tr. 202).

Dr. Eisenberg:Just mother nature and time, both of whjch are excellent helpers and we

see patients many times who a1'.2 made appointments for an acute cphisode ofwhat they call hemorrhoids and if \ve arc not able to see them for severaldays , by the time they come in , much of their symptomatology has been re-lieved , spontaneously, though they have done nothing. So we know from expe-rience that many of th'28e complications will subside spontaneously (Tr. 355).

Dr. McAdams:The inflamatory reaction around the hemorrhoids was induced perhaps

constipation or diarrhea or excessive lifting or straining. It subsides in the

course of that \vhich makes life possible for all of us , Mother Nature s tend-

ency to correct abnormalities.

Time is a great healer (Tr. 488-89),

Dr. Zimmerman:Wen , if a person has irritation in the hemorrhoidal area and the irritation

subsides , just like irritation on the hand , the leg, or anywhere else , if it sub-

sides spontaneously, the body healing will take care of it and the patient wilgradualJy become free from symptoms even though nothing is done Crr. 554),

Dr. Pope:Time itself plays its biggest factor as far a:: treatment other than surgery

and other Ulan injection treatment. Topical application of heat may help andbenefit,

After a period of time, nature herself causes the subsidancc of whatever

symptoms are present.

Yes , \vhich is the usual story in most cases (Tr. 617).Based upon their education , training, and experience , the nine

proctologists gave opinion testimony,' the substance of which

1" The testimony WRS permitted over the objections of respondent s counsel who stated('11'. 127- 28):The qucstion that is being asked of the Ductur as R hypothetical qucstion is one thRt appears

to requil'e e"pert qualif1Cations eithe)' as a 1Jharmacolo ist or a biuchemist, or, at the very

least , thc estRblishIT.ent of some founllation that, th!'ugh observation Rnd clinical tests or us.,or p)'escription on hjs paticnts , he has in fact observed what results, if any, have been achievedwith these pror:'.1cts.

In John J, F1dto1l v. 130 F. 2d 85 , 86 (9th Cir. 1942), the Court said:

The witnesses were shown to possess wide knowledge in the Held under inquiry, There is no

g-ood rea,OI: to sUPvose therr incompetent to express an opinion as to the lack of therapeuticvalue of petitioner b preparation rr. ere y because they had had no personal experience with )tin the treatment of the disease. Their general medical amI pharmacological kno\\"1edge f!ualifieuthPTn to testify

In later decisiuns, the same Circuit empioyed the same language in Feil v. C" 285 F. 2d

878, S93 (1960) and in StrL1lifer Laboratories , Inc. v. C" 343 F, 2d 75, 78, 80 (1965).



was that Preparation H ointment and suppositories containingthe ingredients listed in the formula (CX 7 and 8), when used asdirected , wi1 not: (1) Reduce or shrihk piles; (2) avoid the needfor surgery as a treatment for piles; (3) stop aU itch due to piles;(4) relieve aU pain due to piles; (5) heal , cure or remove piles oreliminate the problem of piles; and (6) have any therapeutic ef-fect upon piles or the symptoms thereof in excess of affordingtemporary relief of minor pain or minor itching associated withpiles. (Hopping, Tr. 128-131 , 173-74; Marino , Tr. 212-215; Man.heim , Tr. 276-79; Eisenberg, Tr. 369-373; Sarner , Tr. 436-440;McAdams, Tr. 500-504, Zimmerman, Tr. 563-66; Pope, Tr.629-633; and Smith , Tr. 740- , 784- , 792-93.

The lack of familiarity on the part of witnesses with some ofthe ingredients in Preparation H is indicated by their testimony:

DT. Hopping:Q. I \\QuJd like to explore for a few minute the basis of some of your an-

swers to a couple of the hypothetical questions put to you on direct examina-tion. Referring to Commission Exhibit 7

, .

arc you familiar with each of

the ingredients listed on there?

A. In a very superficial ..vay, yes (Tr. 162).

Q. What source did you go to Doctor for your knowledge ofA. A resume of its properties ..vere given to me.Q. By whom?A. My. McMahon r complaint counselJ.

SRF?

Is that the sole source of your knowledge of SRF?Yes (Tr. 105- 66).

Q. In these answers that you gave to some of the hypothetical questionsposed to you this morning' about oxyg-en uptake , vitamin deficiency and so

forth , were you answering on the basis of expert kno.wledge in the field ofpharmacology or biochemistry, or were you answering based on the experi-cnce you described in talking fwithJ patients \\'ho have trcated themselvesprior to coming to you?

A. Vlell , since neither my patients who give me the story nor I are expertson pharmacology, I wouldn t expect to formuJate an opinion on these particu-Jar subjects (Tr. 168).

Dr. Marino:A. I have seen Bio-Dyne mentioned in three articles , one medical article

and two articJes in the lay prcss , but this is the only knowledge that I haveof that particular substance. I am aware of shark liver oil as being onc ofthe oils high in vitamin content. Phenyl mercuric nitrate J am not familiarwith (Tr. 210).



Q. . . . I have specifically not prescribed Preparation H because I do notknow what it contains (Tr. 244).

Dr. Manheim:Q. You wil note that on the cartons , 5 and 6 , the active ingredients for

these products are listed as Iive yeast cell derivative, supplying 2 000 unitsskin respiratory factor , bio-dyne , per ounce of ointment or suppository base;shark liver oil, 3.0 percent; phenylmercuric nitrate , 1 fa 10;000. Are you gen-erally familiar with these substances?

A. Some of them; not all of them (Tr. 273).

Q. Do you have any knowledge of the effect that is achieved by combiningthat SRF business with phenylmercuric nitrate?

A. No. I don t even know what is SRF (Tr. 300),

Dr. Eisenberg:Q. Do I understand , correctly Doctor, that your only familiarity with res-

piratory factor reported in the two formulae that you looked at is only fromwhat is said on the cartons containing the products?

A. Yes , sir.Q. I believe you stated that you were familiar with phenylmercuric ni-

trate?A. Only by name. I have heard the name and the fact that it is used as

local antiseptic.

Q. And is that also generally the degree of your fami1iarity, Doctor , withshark 1iver oil;

A. Only that it is probably similar to cod liver oil in its basis.Q. Are you qualified in pharmacology, Doctor?A. No, sir (Tr. 388-89).

Dr. M cAd.rn:

Q. Do you know , Doctor

, .

whether a substance which can stimulate cellularrespiration and proliferation may have a beneficial result on the hea1ing ofinjured tissues;A. I don t know (Tr. 509).

Q. \Vell , what is your knowledge about the effect of combining Biodyne orskin respiratory factor with phenylmercuric nitrate in the amounts disclosedin the right-hand column on Commission Exhibit 7?

A. I have no opinion on that (Tr. 513).

Dr. Zimmerman:Q. Doctor , I sho\v you the following Commission exhibits. . . ex 7 and 8

which are the quantitative formulae of these two products. Would you exam-ine these four exhibits carefully, please?

AMERICAN HOME PRODCCTS CORP. 1547


A. \\ihat is SRF?Q. I am sorry, Doctor , I can t answer that question for you at this point.A. The first thing is SRF Crude Concentrate, and I don t know what it is.Q. For the sake of the question , suppose it means skin respiratory factor.A. I don t know what Falba is , either (Tr. 560-61).

Dr. Smith:(Q.J Are you generally familiar with these , Doctor , these ingredients?A. There is one I don t know anything about. It is called falba. I haven

the least idea what falba is (Tr. 735).

None of the Commission s witnesses , with the exception of Dr.Zimmerman , had treated patients with Preparation H, nor ob-

served the results which might be achieved with such treatment(Hopping, Tr. 151; :Vlarino, Tr. 217 , 221-22; Manheim, Tr. 303;

Eisenberg, Tr. 378-80; Sarner, Tr. 447, 460; McAdams, Tr.511-12; Pope, Tr. 670 , 690-91; and Smith , Tr. 775- , 791-92).On cross-examination , Dr. Zimmerman revealed that in 1959 or1960 , at the request of the Commission s Dr. Hall (who sat with

complaint counsel in an advisory capacity during the trial of thisproceeding), he had undertaken a clinical study of Preparation Hand its use on hemorrhoids. Dr. Zimmerman explained that thestudy took place over a period of about a year or a year and ahalf , and involved two different things. One-each patient , whowould come into his private offce , was asked whether or not hehad used Preparation H , and , if he had , whether it was supposito-ries or ointment and over what period of time he had used one orthe other product or both. Two-at the Falk Clinic, which is con-nected with the Presbyterian University Hospital and a charityclinic for the University of Pittsburgh Medical School , under thedirection of Dr. Zimmerman pictures in the form of color slideswere taken of patients ' internal hemorrhoids. The patients werethen given Preparation H , which was used by them for variouslengths of time from one to three months. Pictures were then

again taken of the hemorrhoids. When respondent' s counsel re-quested the production of these records, Complaint Counsel

McMahon responded (Tr. 584-85).

Mr. Examiner, if you please , sir, we anticipated that this informationmight come forward. The Commission does not rely upon it in any sense , hasnot offered it in evidence , and we do not intend to offer it in evidence. \Ve wi1furnish a copy of the Dr. Zimmerman s report to counsel , but \ve do not feelthat it is legally competent evidence and , therefore , we are not relying on itand have not Pl'€senied it as part of our case in chief.

A report in the form of a Jetter , dated March 6 , 1962 , addressed


Inital Decision 70 F.

to the Commission by Dr. Zimmerman , and 129 pages of clinicalstudies, together with color slides, were forthwith delivered inthe hearing room to respondent's counsel by complaint counsel.FolJowing a short recess , during which period respondent' s coun-sel perused the material supplied him , such counsel stated thatthe studies were not such that they could be analyzed in a shortperiod of time , and asked that , at the conclusion of Dr. Zimmer-man s testimony that morning, the Doctor be excused subject torecalJ for further cross-examination (Tr. 582-590). After somefurther testimony on the part of Dr. Zimmerman , he was excusedwith the understanding that the hearing examiner would give

consideration to respondent counsel's request for the return of the

witness (Tr. 597). A number of days subsequent thereto , respon-dent' s counsel stated on the record that it would not be necessaryfor him to ask for the return of Dr. Zimmerman for furthercross-examination (Tr. 1804). It should be noted that the testi-mony given by Dr. Zimmerman was not based on the results ofthe clinical studies made by him of Preparation H.

As to the effcacy of suppositories and ointments in the treat-ment of hemorrhoids , the nine proctologists testified in part:

!Jr. Hopping:Q. In prescribing such ointment or suppositories, what effects \vould you

rxpect to be achieved by their use

A. Decrease in the immediate complaint or symptom of the patient.Q. Do you propose to cure the hemorrhoids by these measures?A, , sir (Tr. 121).

A. Topical applications can re1ir:ve the symptoms of hemorrhoids , yes.Q. Is this a permanent rc1ief of symptoms?A. This is temporary.Q. \Vil this relieve the severe symptoms or the minor symptoms?A. To a certain extent , it will relieve some of the severe symptoms and

some of the minor symptoms (Tr. 122).

Q. Again , Doctor , do you have an opinion as to whether any medicationointment , suppository or combination of them will cause hemorrhoids to ceaseto be a problem?

A. Temporarily, yes , they might very 'v' cn.Q. And on what basis?A. That it relicves the symptoms of the disease.Q. \Vill it relieve all of the symptoms?A. Xo. sir (Tr. 125).

A. Yes , sir. They may very well relieve the symptoms of the acute attack at

AMERlCA!- HOME PRODUCTS CORP. 1549


the moment, but theyeffect a cure (Tr. 128).

(Preparation H ointment and suppositories) do not

Prepara-Q. On the rare occasions that this does occur , would you say thattiOD H ointment or suppositories will eliminate all of the itch?

A. They may temporarily do so , yes (Tr. 129-130).

By Mr. McMahon:Q. Doctor , I am concerned about that salesman in Chicago that called you

long-distance and you stated , I believe , that you prescribed Preparation H forhim. What was your purpose in prescribing Preparation H for this patient?

A. Well, on the basis of what I knc.w about him already, as I prefaced mystatement then. I said I had examined him previously, two years before , in

the offce. I knew that he had a skin problem as well as hemorrhoids, andfrom his immediate story I tried to in my mind go through the simplest pro-cedure to give him relief of this intense discomfort that he was having in hisanal recial area. I can t send him a prescription over the phone. The simplestthing I eould ask him to do \vas to go to a drug store and ask for some Prep-aration H. 1 did that on the spur of the moment.

Q, You did not expect this to cure the hemorrhoids?A. Ko, sir,

Q. 'Vould tJ1e prescription of any other lubricant material have been justas effective as the prescription of Preparation H in his case?

A. Any other lubricant? No , I don t think so. He couldn t have used Vase-line , for instance, or a simple petrolatum \vith anything more than aggrava-tion of the symptoms (Tr. 176-78).

Dr. lVlarino:Q. I gather from what you said that on occasion you do prescribe oint-

ments or suppositories for your patients for the relief of symptoms of hemor-rhoids. What circumstances would prevail for you to make such a prescrip-tion?

A. If a patient were having a hard , dry stool , a suppository would be veryneficial to lubricate the anal canal. If a patient with protruding hemor-

rhoids were experiencing chaffng due to undergarments scraping against thehemorrhoid, I think a lubricating ointment is very beneficial (Tr. 203-204).

A. If hemorrhoids are present , there is , in my opinion , no suppository orointment that is going to cure the underlying pathology. While the symptomsmay be relieved temporarily, another attack of inflammation in the hemor-rhoid \vill produce a recurrence of the same symptoms (Tr. 206-207).

Q. .. do you have an opinion as to whethersuppositories . wiIl reduce or shrink piles?

Preparation H ointment or

A. I do not think they wil shrink piles.Q. 'Vil they reduce piles?



A. If so far as any lubricant '.vQuld reduce or aid in reducing the skin

edema overlying a pile , they might give temporary and minor relief.

A. Yes , it ,vil not avoid the need for surgery in the treatment of piles.

A. . . . Unless the venous dilatation is eliminated , the piles or hemorrhoidswil not be cured (Tr. 212-13).

with hemar-

in the tissue

Q. Isn t it true that many of the symptoms that a patientrhoids has , in terms of a direct effect , come from a pathologyrather than from the vein itse1f?

A. I think that is true , yes (Tr. 235).

Q. If you clear up those pathological tissue conditions entirely, just assum-ing you can do that, do you then have an asymptomatic hemorrhoid?A. You wouJd , temporarily.Q. How temporarily, until the next exciting attack of something?A. UntiJ they became symptomatic again.Q. How long might that take?

A. It might take quite a ".hile. I really would have no basis for answeringthat question (Tr. 235-36).

Dr. Mnnheim:A. They arc all worthless.Q. Would you please state your reason?A. I have never seen a patient who has had any relief from any ointment

or suppository, except the lubricating effect.Q. Could they achieve this same lubricating effect with any lubricating

substance?A. Plain vaseline (Tr. 269).

A. My opinion , based on patients ' histories to me and my examination ofthem , is that Preparation H, in the form of suppositories or ointment , has8bsolutely no beneficial effect on Hemorrhoids (Tr. 276).

A. I don t think that anything in the Preparation H suppository or oint-ment will even give minor relief , except the lubricant value.

HEARING EXAMIXER JOHXSON: And what is the value of the lubri-cant?

THE \VIT:!T ESS: It relieve's dryneo:s of the skin. It relieves dryness of theanal canal. Anything that you put in tnc anal canal or rectum would ease thebowel movement tnroug-h. The lubrication effect of the ointment can cause aneasier bowel movement and with an easierbmvel movement, there would beless minor irritation , but this could he accompJishcd \vitn vaseline with muchless danger (Tr. 279-280).



Q. Isn t the substance of your testimony today that there isas drug of choice in the treatment of hemorrhoids?

A. I would say there is none (Tr. 308).

no such thing

A. . . . Frequently, people wil say to me

, "

It feels a little better if I putVaseline on it.

I say. " If it feels a little better , use it" (Tr. 312).

Q. . . . However , is it your testimony now that lubrication in the form of atopical application will have no beneficial effect on a hemorrhoid?A. Oh , no , it must have some.Q, What is it?A. A feeling of ease, a feeling of smoothness , Jess dryness (Tr. 313).

Dr. Eisenberg:A. . . . Many of these patients of self-medicated themselves on more than

one occasion and when asked specifically, which we often do ask , do you thinkthe medieation helped you any, some wi1 say definitely yes , and how long didit take , well , I was all better in ten days or t\\'o weeks. We know that some ofthese proetologic symptoms will relieve themselves in that length of time , oreven a sho1'te1' pedod of time. So iha t generally, I would , in my own opinionthis self-medication does not relieve the vast majority of these patients (Tr.

361).

A. My opinion is that this docs noi do good in most instances.Q. Would you state your reasons? I am sure you have said this before.A. Well , my reasons are these :That these patients come to me as they do

to others in my specialty, for relief when these praparations have failed togive them relief. I don t know ho.w else to state it, sir (Tr. 363).

Q. Doctor , on the basis of your professional education and training and ex-perience do you have an opinion as to \-1,hether any preparation is appliedtopically or as a suppository will afford any relief from pain and itching as-sociated with or attributed to hemorrhoids?A. Yes , there are some. There are some whieh wil afford relief. But these

are affording relief to the complications which have occurred in those hemor-rhoids.

Q. Are they affording any relief to the hemorrhoid itself?A. I don t believe they do, sir.

Q. In other words , you are saying that in your definition of the hemorrhoidas a collection of varicose veins, that the applieation of these preparations

does not get to them , is that the substance of your statement?A. That is correct (Tr. 365).

THE WIT;.ESS: I have an opinion and my opinion is that it wil not healeure , or eliminate piles. May I add , the simple application of any harmlesspreparation may aI1eviate some of t1H' symptoms but will not cure (Tr. 372).



Q. My question is specifically addressed to the patients \vhom you have seenon successive occasions, so that you feel able to state that their hemorrhoidswere in substantially the same condition after they had used Preparation Has they were prior to the time that they had used Preparation H.

A, I feel , sir , that I cannot answer that question. The only way that I haveof making a positive statement would be jf I had prescribed Preparation Hand then had these patients come back at intervals so that I could see theeffects that the preparation might have had. But the patients whom T see orwhom I have seen ' who have used tbis are those \\'ho have used it either ontheir own or on the advice of friends or pharmacy and who then come to meand say that I have used it and here I am , please do something else (Tr.376- 77) .

Q. In your opinion , Doctor, is the natural healing process or natural sub-sidence of hemorrhoids in cases where that is going to occur apt to be as-

sisted by some treatment which may relieve the complications which are pre-sent in the hemorrhoids?

A. Yes.

Q. In your opinion , does a relief of the edema if it is present assist thenatural healing process?

A. The reJief of the edema is part of the healing process.Q. If infection were present, would the relief of such an infection assist

the healing process?

A. If it were possibJe to re1ieve the infection , yes.Q, And is protection of the protrusion or buldge of the mucosa in an inter-

nal hemorrhoid of assistance to the natural healing process?A. Yes.

Q. Would you agree , Doctor, thai iJwre may be patients \vith hemorrhoidswhich , if not treated in conservative fashion , may develop such complicationsthat fhey may have to undergo surgery whereas surgery might not have beenrequired in those cases had the problem been caught at an early enoughstage?

A. Probably in some instances (Tr. 380-81).

A. Yes , I think that one of the most frequentIy prescribed suppositories inmy practice is a preparation kno\'m as desitin suppository which is basicallya cocoa butter base and cod liver oil.

Q. Are there any other active ingredients in the desitin suppository thatyou know of?

A. Not that I know of (Tr. 382).

Q.. . If you can , in an internal hemorrhoid protect the en1argement inthe mucosa against t.rauma , reduce inflamation , relieve the edema, perhaps ifit is present , aameliorate the infection. \Vould not ihat kind of treatment as-sist both in reducing the possibility of further complications and perhaps inreturning the hemorrhoid to its asymptomatic state?

A. Possibly (Tr. 387).



Q. Isn t it a fact, Doctor, that some cases of hemorrhoids respond we11

enough to conservative treatment that surgery is not necessary?A. Oh , yes (Tr. 388).

By Mr. McMahon:Q. To go on with the question , would the topical application of Preparation

H or any other ointment stop rectal bleeding wnose source was an internalhemorrhoid?

A, Possibly.Q. In what way would this be effected?A. In the fact that it would act as a protective coating and may, by this

fact promote healing-allow it to heal.Q, Allow what to heal?A. The mucosal surface that is bleeding.Q. Would this have any effect on the underJying hemorrhoid?A. No , sir , I feel it would not (Tr. 403).

Dr. Sarner:A. I prescribe ointments. Never a suppository.

Q. Under what circumstances would you prescribe an ointment?A. Chiefly to facilitate reduction of prolapse . We recommend patients who

have prolapse that they have hemorrhoidectomy but for some people who arepoor risk because of severe heart involvement, or I can recall a leukemiapregnancy in the wrong trimester , we prescribe palIiative things , principallytopical steroids which are not curative but are palliative. They reduce itchingin many people. . (Tr. 426-27).

Q. What are your observations as to the results that have been achieved bysuch medication with Preparation H or any other ointment?

A. The patients who seek my care obviously have not benefited (Tr. 428).

THE WITNESS: At best they have a pallative effect , but-and no defini-tive effect on hemorrhoids.

By Mr. McMahon:Q. Would you state your reasons for this?A. Well , if we define hemorrhoids as we have defined them , no ointment is

capable of restoring a deficient , muscular coate in a vein to normal. The onlyeffect could be some alleviation of the results of the varicosity but could haveno effect on the varicosity itself (Tr. 429).

Q. If you can arrest or clear up those problems in the overlying or sur-rounding tissue , would it not assist the natural processes of the body which that hemorrhoid may be subsided?

A. If you could do that , yes.Q. If you could do that?

A. Yes.



Q. Do you doubt, Doctor, that you can do that in some cases.A. Overcome Infiamation?Q. Edema or infection?A. It can be done in some cases (Tr. 460).

Q.. . I would like your opinion as to the effcacy of Preparation H ..dthregard to the treatment of edema, inftamation and infection in tissue overly-

ing a hemorrhoid?

A. I don t think it would affect it beyond this phenylmercuric nitrate if itis antiseptic. It is not ant.iseptic. It has bacteriostatis properties according tothe information that I have. It might influence an infection favorably. Theother ingredients I don t know-I can t really state because I don t know

how effective phenylmercuric nitrate in this dilution wou1d be. The di1ution

becomes outrageous as soon as it mixes ,vith the other fluids present (Tr.463-64).

Dr. McAdams:A. No , it could

defect (Tr . 481).not cure hemorrhoids , because it cannot alter a structural

A. That opinion is that the effect would depend upon the vehicle largelywith which it was applied.

Q. \Vould you explain a little more ful1y?A. Well , there are any number of things that would make anything sore

feel better and the ordinary ointment bases, such as lanolin and vaseline

would have the effect you describe (1'1'. 482).

A. By cure , you refer to an absolute cure , not amelioration of symptoms ora restoration of an asymptomatic state , but-

Q. A cure.A. There is only one way to really cure hemorrhoids and that is to remove

them surgically.Q. In terms of effec6ng a cure , is there any other treatment available?A. Not if we use the word " cure" in the sense I just talked about (Tr.

487).

A. . Vle sometimes prescribe Anusol , a suppository which contains-most all suppositories o.o-a cocoa butter base which actualIy is a majorpart-wherein lies a major part of the advantage, but which also contains,T believe , balsam of Peru and bismuth.

Q. Xow under what circumstances would you prescribe such medication,Doctor?A. I would prescribe such medication when a patient with hemorrhoids

came in with an acute infiamatory reaction due to strain as a resu1t of consti-pation or diarrhea , that would be common

Q. Now , in prescribing such ointments or suppositories , what effect do youexpect to be achieved by their use?

AMERICAN HOME PRODGCTS CORP. 1555


A. We expect them to make the patient more comfortable until the inflam-matory process and the swelling recedes.

Q. Do you expect the hemorrhoids to be cured?A. No. The hemorrhoids are stil there aft r the patient is rendered com

fortable and after the swe1lng- has subsided (Tr. 490-91),

A. Wen, we have a number of patient who have a basic hemorrhoidal prob-lem which is quite tolerable unti something comes along to produce someswelling or inflammation. Either they, or their own , or I prescribe somethingsoothing and lubricating to the area and that gives them some relief.

Q. Again , is this temporary relief that you aTC referring to , Doctor?A. Well, this is relief for that particular acute episode of pain and dis-

comfort (Tr. 493).

A. Yes, I have an opinion, and I believe that an acute episode of hemor-rhoids and inflammation 01' swelling can be relieved, along with the healingpo,ver of time , to the point where they wil , at least for the time being, ceaSeto be a problem (Tr. 494).

A. There are many factors that enter into the reduction of hemorrhoids orpiles. What portion of that reduction would be attributable to the applicationyou put upon it, upon the hemorrhoid, and what portion of thatreduction would be due to the natural tendency for these hemorrhoids to re-turn to the original state , I have no way of knowing (Tr. 500).

A. Many of the patients whom I see and subsequently are subjected to sur-gery for the removal of hemorrhoids have already used this preparation overan appreciable period of time and found that it does not solve their problem(Tr. 501).

Q. Doctor , when you used the word "temporary" on a number of occasionsin your direct testimony, in context such as temporary relief , were you usingthe term to mean until the next episode occurs?

A. I was using the term to mean until the acute episode subsided; the pre-sent episode subsided.

Q. And temporary in the sense that it is relieved until another acute epi-sode occurs?

A. No, I don t believe that is quite what I meant. One never knows whenhemorrhoids are going to become symptomatic suffciently to require medica-tion , so I don t assume that what I apply today wil protect that patient forany specific length of time.

Q. '\Tell , you were using the word , weren t you , Doctor , to differentiate , ba-sical1y, between-or to differentiate from the kind of absolute relief you getfrom a cure? Isn t that correct?

A. Yes, that is correct (Tr. 506-507).



Q. Now, if this enlargement can be protected against trauma, and if someof the secondary complications to which we have referred can be cleared up,may the hemorrhoid be returned to an asymptomatic state?

A. Yes (Tr. 509).

Q. Now , Doctor , in the hemorrhoid we were talking about a few momentsago , if it returns to an asymptomatic state , that patient hasn t been cured inthe absolute sense, has he?A. No.

Q. He stil has the underlying vascular anatomical weakness?A. That is correct.Q. But his hemorrhoids have ceased to be a problem to him , is that not so,

Doctor?A. That is correct (Tr. 509-510).

A. When a patient comes to me and it is decided that he should be admit-ted to the hospital for surgery and there is a lapse of time between my exam-ination and the admission to the hospital , I usually inquire as to what he hasdone to manage to get along up until that point; and whatever it is , whetherit is Preparation H or anything elsc, I say, u Now , if you have learned to getalong with these by using this , you continue to use it until you are admittedto the hospital for definitive treatment" (Tr. 511-12).

Q. What is the drug of choice for the treatment of hemorrhoids?A. I don t know (Tr. 513).

Q. And you have also expressed the opinion, I believe , that as long as thatunderlying vascular abnormaliiy remains, that particular person is eithergoing to continue to have hemorrhoids or is going to be subject of recurrent

attacks of hemorrhoids. Is that not so , Doctor?. He is going to have hemorrhoids , and he mayor may not be subject to

recurring aggravations of them , but the hemorrhoids are there and ,vil al-ways be there.

Q. Now, when you say recurring ag'gravation , you are speaking in termsof symptoms?

A. Yes (Tr. 516).

Dr. Zimmerman:A. What causes the pain is the distention of the tissue , especial1y skin , and

after the skin and tissue has once becn distended , the pain usually stops.

Then, as this clot dissolvcs spontaneously and unless they are very large

many of them djssolve spontancously after the skin has been stretched , thepain stops and the clot dissolves spontaneously and nature cures the condition(Tr. 554-55).

A. The patients seem to get some relief from applying these variousthings , but I have never seen them cure it. It is hard to evaluate just how



much good , if any, these things do, because one patient wil come in with a

thrombosed hemorrhoid and say "I put nupercainal on this " a topical anes-

thetic

, "

and it helped " and the next patient comes in and says, 1'1 put nuper-

cainal on it , and it didn t help. But I think anyone feels better if he puts alittle something on a p1ace that hurts or is irritated , but I have never seen

these things cure any condition (Tr. 556-57).

A. They do practically no good.Q. Would you state why?A. Because hemorrhoids aTe under the mucous membrane , under the skin

and unless the skin is lnvolved , the mucous membrane is involved , anythingthey put on there is not going to do any good (Tr. 557).

Q. Afford any relicf from pain and itching associated with hemorrhoids.

That there are some topical things that might give some relief (Tr.558)

Q. Doctorsuppositoryproblem?

do you have an opinion as to whether any medication , ointmentor combination of them wi1 cause hemorrhoids to cease to be a

. I don t think it would cease to be a problem (Tr. 560).

A. It will not reduce or shrink piles.Q. Wil you state why again , sir?A. Again , piles or hemorrhoids are

f'kin or mucous membrane above that(Tr. 563-64).

varicose veins and what is put on theI can see no way it would shrink them

A. I do not believe it will do anything except afford a temporary minorrelief.

Q. Would you state why?A. Again, for the same reason that the hemorrhoids are varicose veins

they are under the skin or under the membrane , and whatever is put on topof the skin or membra nee can have little effect on what is under it (Tr. 566).

Q. No\v, Doctor, where a patient has a hemorrhoidal problem \vhich iscausing him symptoms , there is more involved in that problem than simplythe varicose veins , isn t there?

A. Yes.

Q. The tissue is involved to some extent and the overlying mucosa , isn

that so?

A. Yes.

Q. And his problem , his immediate problem is made up of all those things;the veins , the tissue and the mucosa , is that so'?

A. Yes.



Q. Now, you expressed the opinion , Doctor, that a topical application ap-plied either to the mucosa, when you have an internal hemorrhoid, or to theskin , when you have an external hemorrhoid, couldn t penetrate deeply

enough to effect the varicose veins. But you ,..Quld agree , wouldn t you , Doc-tor, that where you have a symptomatic hemorrhoid involving the tissues andthe mucosa as '\vell as the vein , that such an application could have a benefi-

cial -effect on the mucosa?A. Yes (Tr. 571).

Q. Now , Doctor , if you can prevent or clear up infection and prevent orclear up irritation to relieve edema , protect against trauma , may that nothave a beneficial effect on the symptoms which a patient is suffering from hishemorrhoidal problems?

A. Yes.

Q. And if you can do those things, may it assis(tJ the body s natural

processes in causing those hemorrhoidal problems to subside?

A. Yes (Tr. 577).

Q. . . . If, as a result of clearing up the types of complications we havejust been talking about, and as an added result of the body s own naturalhealing processes , a hemorrhoid subsides so as to render a patient symptom-free , that symptom-free condition or that disappearance of the hemorrhoidalsymptoms is only temporary, is it not , in the sense that the underlying vascu-lar abnormality remains?

A. Yes.

Q. And is that the situation that you intended when you have used theword " temporary" in terms of relief that might be achieved in some casesfrom conservative management?

A. Yes (Tr. 578).

Q. But if something is done at some stage to protect that enlargementagainst further trauma and perhaps to clear up things like infection , inflam-mation and edema , that patient may avoid the need for surgery, may he not?

A. That is one factor.Q. Well , I don t want to be putting unfair questions to you , but if you can

answer my question yes or no , I ,,,ould appreciate it. If you can , you mayexplain.

A. I would have to say yes , anything that decreases the irritational causeof hemorrhoids would be a benefit; for one of the causes of hemorrhoids, itwould be a benefit (Tr. 580-81).

Q. In your opinion , Doctor , is there anything in Preparation H that wouldclear up infection , clear up edema , protect ag'ainst trauma?

A. Yes. The Preparation H is an ointment , it is a grease , and it would lu-bricate the canal and prevent a certain amount of trauma.

Q. And is this Jubricating effect one that cou1d be achieved with a numberof other lubricants?

A. Yes (Tr. 592).



Dr. Pope:A. For hemorrhoids, I give no medication that way at all , unless we have

an u1cerated condition with a very severe strangulation and usually necrotictype of prolapsed hemorrhoidal tissue. And that is for the relief of hemor-rhoids but for the ulceration of the skin over the hemorrhoids and distin-guishing between the treatment of hemorrhoids and the condition of pain anddiscomfort (Tr. 620).

A. The opinion is that the use of suppositories is of value only in lubrica-tion and that again, as far as having any effect on the patient is concerned

used only with the complicated hemorrhoids.

Q. What is the use of ointments?A. Ointments arc for their lubrication value only, excepting where you

have open ulcerations immediately treated , but is not the treatment of hemor-rhoids , but the skin and tissue overlying them , or in some condition which isthought to be hemorrhoids which , after proper examination and diagnosiswould show not to be due to hemorrhoids itself (Tr. 621-22).

Q. Again , Doctor, do you have an opinion as to whether any medicationointment , suppository, or combination of them wil cause hemorrhoids tocease to be a problem?

A. The opinion is that there is none (Tr. 624).

A. The opinion is that it has no effect "whatsoever as far as the treatmentof the hemorrhoidal condition in itself, as far as ihat condition in itself isconcerned (Tr. 628).

A. The reason is that there is a vein underneath the integument , the cover-ing, under the muc(oJus membrane of the skin that can t be reached by thedrug,. . . (Tr. 628-29).

A. I would noi agree that even with minor pain and minor irritation thatit gives any particular relief , and it certainly doesn t in those symptoms thatare more severe it certainly would not in those conditions that are alreadymore marked than just even moderate which refers to itching, pain , as wellas al1 other symptoms (Tr. 633).

Q. What is the drug of choice for the treatment of hemorrhoids?A. There is no drug of choice in the treatment of hemorrhoids , excepting

where partial improvement can be used by injection treatment which could beas far as the drug of choice of the various drugs that are used for that , thatwhich is used the most in '\vhich I use is a five percent solution of quinine-uria hydrochloride.

Q. That is for injections?A. That is for injections (Tr. 634).



A. If other conditions arc ruled out and you are deflnitely treating thataIone , yes. It is not necessariIy a vein of importance to treat it. I would haveto say that , necessariJy; but, if you showed your attacks became more fre-quent and you are sometimes involved in something that is more marked forsevere pain , then those are the indications for treatment (Tr. 650).

Dr. Smith:A. . . . External hemorrhoids, or external-let me put it this way-any

condition causing an irritation of the rectum can be given symptomatic reliefby the use of certain medications or certain ointments , any lubricating medi-cine , oil or petroleum , vase1ine or any other lubricant wil then prevent theirritation of the stool on the outside , and \vould be helpful in treating symp-toms due to this particular condition (Tr. 723).

A. . . . I have never seen any ointment which cangoing to cause a resolution of this thing more quickly

been applied (Tr. 726).

be applied which isthan if nothing had

A. That other than the relief of mild irritation , they are of no value as faras the hemorrhoids themselves are concerned (Tr. 730).

A. I mentioned before the use of emo11ent types of ointments , the use ofan antiseptic agent applied locally may give some temporary and some mildrelief (Tr. 732).

A. And that while such things may be of temporary benefit as far assoothing is concerned, they have no effect whatsoever on the hemorr"!oid, andhence they cannot cure hemorrhoids (Tr. 733).

A. That they do not cause the hemorrhoids not to be a problem (Tr. 734).

Q. The overlying tissue , however , may be treated perhaps even to a degreeof rendering the symptom-of rendering it symptom free by measures shortof surgical excision , is that not so?

A. I testified to that before when I stated that irritations of the skin wouldbe helped by the use of ointments , et cetera , any type of emollient prepara-

tion , yes.Q. Including irritations of the skin or mucosa overlying the hemorrhoidital

varicosity?A. That is correct (Tr. 745-A).

Q. Now , are you using temporary in the same sense both \vith respect torelief and with respect to cessation of symptoms?

A. That is rather diffcult to ans\ver because I may see people who may notbleed for ten or fifteen years.



No\v, if you want to call fifteen years a temporary thing, then it wouldhave to apply. :My use of the word temporary was in reference , in the frameof reference to the specific episode that brought them into my offce.

Q. And if you relieve that specific episode as for example if you suc-(cJeed in stopping the bleeding, that is temporary relief , is it not?

A. I .would say temporary because it doesn t necessarily follow that in

every instance the man is going to bleed again.Q. Yes , but it is temporary in the sense that short of surgical excision he

is stil going to have that varicose dilation of the veins?

A. That is correct, but it doesn t necessarily follow that that hemorrhoid isgoing to give him trouble again because we don t operate on a hundred per-cent of the people (Tr. 769 770).

Q. And if you can relieve that edema may you be ableA. That would follow (Tr. 771).

to relieve the pain?

Q. And the ointment may have some beneficial effect in treating that,might it not?

A. It may, because if you cut the skin , it is going to be sore, so you put alocal anesthetic agent or some soothing agent unti the skin regenerates andtheir problem is over.

Q. And does this sort of treatment have a beneficial effect on the patient'symptoms from hemorrhoids?A. It helps their symptoms, but it doesn t help their hemorrhoids (Tr.

778-780) .

Q. Well , now, does it , on occasions , occur that a patient of yours for whomyou prescribed one or more of these ointments plus the other conservative

methods used-you have referred to, wil become symptom free?A. Yes, I think so.Q. And he has gotten temporary relief?A. If you want to call cessation of symptoms as temporary relief, I agree

with you. I think it is a question of semantics (Tr. 780-81).

Q. Beyond lubrication , would Preparation H be of any benefit in the treat-ment of external hemorrhoids whieh are ulcerated or infected?

A. It does contain an antiscep--an agent, Phenylmercuric nitrate is inthere, which is one of the antibacterial things under certain circumstances

which might be a plus in lubricating value (Tr. 792).

Q. In your opinion , Doctor , \vould Preparation H ointment relieve theedema , inflammation , irritation such as occurs with the ulceration or inflam-mation of external hemorrhoids?

A. Again in answering that question , I am sure that any type of emollentointment, and this would include Preparation H , \'lould be of some minorhelp, or let me say would be of some help for minor complaints , such as irri-



tation , et cetera. I think that would be a true statement, yes, sir (Tr.792-93) .

The Commission witnesses , who testified on the subject , statedthat a large number of their patients came to them as referralsfrom other physicians:

. Hopping:A. Most of them.Q. Ninety percent?A. Or better (Tr. 139).

Dr. Marino:A. Yes, sir , the majority of our patients (Tr. 225).

Dr. Manheim:

A.

. . .

In the early practice , when I kept a graph , it was a very high per-centage of doctors. Now , it is about even , 50- , from doctors and from otherpatients (Tr. 286).

Dr. Eisenberg:A. Yes , sir, most of them (Tr. 383).

Dr. Sarner:A.

. . .

50 per cent by patients and 50 per cent by professional colleagues

(Tr. 458).

In the treatment of hemorrhoids , the proctologists utilize sur-gery (the operation is known as a "hemorrhoidectomy ) in a sub-

stantial number of their cases. Dr. Hopping operates on about 200to 250 of his hemorrhoid patients annually. He estimated thatthree out of four of the patients he sees are operated on either byhimself or by other surgeons (Tr. 133-34) ; Dr. Marino sees be-tween 12 and 15 new patients a week, and in a year operates onabout 120 to 125. Some are not operated on because of the pa-tient' s general medical condition, and others choose not to have

surgery. Frequently, when surgery is recommended, the patient

wi1 go back to his referring doctor (Tr. 223-26) ; Dr. Eisenbergsees between 300 and 400 hemorrhoid patients a year , and esti-mates that 60 to 70;70 go to surgery (Tr. 382-83) ; Dr. Sarner,who operates on "Somewhere between 200 and 250" of his pa-tients in a year (Tr. 459), said

, "

Even a conservative man wouldhave to operate on half the hemorrhoids he sees" (Tr. 467) ; Dr.

McAdams operates on about 250 a year , stating that the total ofhemorrhoid cases which he sees in such a period would be morethan double that number (Tr. 510) ; Dr. Zimmerman estimatedthat he performed about 300 to 350 hemorrhoidectomies last year



(Tr. 578). Patients who have problems such as severe diabetes,high blood pressure , and heart conditions are not suitable sub-jects for surgical care (Hopping, Tr. 134; Marino , Tr. 226, 244;

Sarner, Tr. 426). Some patients choose not to have surgery, al-though surgery is recommended. Dr. Hopping explained

, "

A goodmany people that I see want to be reassured , and when you te11them they have hemorrhoids , they say, 'This is fine. I know whatit is. Can I live to be ninety or hundred with hemorrhoids?' Isay, ' Yes, indeed , it doesn t ki1 you.' They are perfectly content togo along with their disability" (Tr. 135; Marino, Tr. 226).

As to respondent's defense, at the outset consideration wi1 begiven to the testimony of the six doctors who participated in clin-ical studies of the products involved.

Dr. Young, a Fe110w of the American Co11ege of Surgeons anda diplomate of the American Board of Surgery, has performed be-tween 20 000 and 25 000 operations during his career since 1934.

At the time he appeared as a witness , in addition to carrying onhis private practice in his specialty as a general surgeon andbeing an instructor in surgery at Ohio State University, he was

the director of the Institute of Medical Research, Inc. of Colum-bus , Ohio. This organization was formed in 1950 for the purposeof industrial medical research and the testing of drugs

, "

bringinga number of men together who have various talents in the medi-cal field to work together to this end" (Tr. 1445). The Institutewas recently requested by the Federal Trade Commission to reviewsome books relating to the medical practice , and Dr. Young issuedan opinion giving his views with reference to the validity of some

of the statements contained therein. Dr. Young testified that atthe present time he sees between 50 and 100 hemorrhoid patientsin the course of a year, and that most of these cases are medicalfailures and require surgery. He estimated that about half of thepatients are referred to him by other physicians-usua11y for sur-gery. For the patients who are not operated on

, "

We inquireabout the character of their stoo1. If their stool is hard , we givethem a stool softener , rcommend sitz baths and treatment withsuppositories or ointment , or both" (Tr. 1450). Dr. Young wasthe medical director of Curtis Wright Corporation from 1942 to1949, and North American Aviation , Columbus Division, from1949 to 1956 when there were about 20 000 people in their plant.. . . we saw or had around 250 000 visits a year to our hospital

and first aid rooms. And hemorrhoids are a rather commoncomplaint. . . . When I was at North American and Curtis



Wright I saw more of a cross section problem" (Tr. 1446-47). Atthe request of Dr. John M. Shaul, Medical Director of Whitehal1

Laboratories, a division of the respondent corporation, during1958 and 1959 Dr. Young undertook a study of Preparation H

suppositories and ointment for the purpose of giving an opinion

as to whether or not the products were effective in the treatmentof hemorrhoids and what the side reactions were. As to thesource of the subjects used in the study, Dr. Young said (Tr.1457) :

Some of them were my own private patients. In order to get additional pa-tients I asked nurses and medical directors in industry who WCTe friends ofmine (iJf they would send patients who were wiling to be placed on thetrial at no charge to them. And the patients that were on the tria! broughtother patients who they knew were suffering from hemorrhoids , also. Thenwe found patients in some ten or bvelve Test homes and also patients in thecity prison in Columbus , Ohio.

Some of the subjects were to be pregnant women , and , as Dr.Young did not see those in his practice , he made an arrangementwith Dr. Burt , an obstetrician , who occupied an offce next to him.When Dr. Burt selected a patient for the study, he would cal1 Dr.Young and the two doctors would examine the subject. This pro-cedure was fol1owed on subsequent visits during the period of thestudy. There were times when Dr. Young was not available andin such instances Dr. Burt did the follow-up by himself and gaveDr. Young the results of his examination. Each patient used inthe study was told by Dr. Young that it was a clinical investiga-tion , and that he did not know whether the product would be ofvalue or not. The patients were not told what the product was.

The suppositories used in the test were contained in a plain , whitepackage , and the ointment in plain tubes with no marking there-on to identify the product. The patients were instructed to usethe medication after each bowel movement and at night whenthey went to bed. The patients were also instructed not to use anyother type of medication or treatment. After the initial visit , thepatient was seen again in three or four days and at intervalsthereafter until there was no further need for observation. Oneach subsequent visit , the patients were again instructed not toemploy any other measures than the ointment or suppositoriesand anybody who used any other type of medication or treatmentwas then out of the study. Dr. Young recorded the resultsachieved by 127 patients (including 19 patients observed with Dr.

Burt) who were treated with Preparation H in the course of the



study (RX 5A-5Z103). Dr. Young stated that, as a result of thestudy, he has prescribed the preparation in the course of his regu-lar practice (Tr. 1468). Based on the clinical investigation and onhis experience with Preparation H since that time , Dr. Young tes-tified that Preparation H is effective and worthwhile in the con-servative treatment of hemorrhoids, wi1 reduce the swelling,edema , and size of enlarged hemorrhoids , wi1 relieve pain , andstop and relieve itching (Tr. 1470-72). Dr. Young also testifiedthat the study influenced him to the point that he subsequently

used Preparation H to treat his own hemorrhoids (Tr. 14731512). The basis for some of Dr. Young s opinions is il1ustratedby his testimony on cross-examination:

Q. You gave the opinion , Doctor , that Preparation H would reduce hemor-rhoids in size. You also stated , Doctor , that this would have no effect on thevaricose veins that "vas underlying the integument over it.

A. That's true.Q. SO that even though you applied the Preparation H , the varicose vein

would remain as before , is that Tight?A. V, ell , basically that' s right, with inflammation and edema present , there

may be some local obstruction to the vein "\vhich at the time is in the acutephase and makes it larger than it will a month later but you never can , in myopinon , eliminate the basic varicose vein by the use of this ointment or sup-pository preparation (Tr. 1497).

Q. What about in the relief of pain , Doctor? Vlhat is your opinion withregard to Preparation H in this circumstance?

A. I think it' s of value.Q. \Vill it relieve all pain , Doctor , associated with or ascribed to hemor-

rhoids?A. Within a matter of a ShOlt time and I mean by that within 12 to 24

hours , patients say that they receive some benefit and within a week , most ofthe patients say that pain has disappeared (Tr. 1497-98).

Q. Doctor , do you have an opinion based on your education , on your train-ing and experience and your clinical study that you have reported to as to

whether Preparation H ointment or suppositories contains the active ingre-dients that are presently in them and used as directed wil avoid the need forsurgery as a treatment for piles or hemorrhoids? Do you have an opinion?

A. It .would have to be a qualified opinion.Q. Would you give your opinion , please , sir'?

A. I would say that in the majority of cases as seen in a cross section of

the population , as I sa\v it at Curtis Wright, and Korth American , that it\vas effective and would be successful enough that surgery was not necessarybut it certainly would not prevent all cases from developing to the point

where they need surgery.



Q. Doctor, I'm sorry but you confused me. Would you re-state your answerplease , sir?

A. In a cross section of the population, where you see hemorrhoids of allkinds, that the conservative treatment is suffcient to render the patientasymptomatic and that surgery is not necessary in most of these patients.However , it will not prevent the necessity of surgery in all hemorrhoid pa-tients (Tr. 1500-1501).

Q. Now , Doctor , if you have a patient who , in your opinion , should have ahemorrhoidectomy performed and there are no other physical conditions pre-sent that would contrain.dicate surgery, do you feel the application of Prep a-

raton H ointment or suppositories for the patient would eliminate that procedure?

A. I think you are in a situation where you have to make a decision as towhether to keep this patient. under constant conservative treatment with pe-riods in which your treatment is a failure to some extent , or whether you aregoing to subject him to surgery in the hope that al1 this may be e1iminated.

I personally think that it' s better to do surgery in this particular type pa-tient and get away from the constant treatment.

Q. I see.Doctor , do you have an opinion as to whether Preparation H ointment or

suppositories wil eliminate all itch due to or ascribed to piles? I want you totake particular note of the word "alL"

A. In this series , we had 28 patients that reported itching and 27 re1ieffrom itching.

Q. Doctor, I don t think that s responsive to my question.A. Wen , a11 of the patients were not relieved from itching. One was not.Q. Were they reliev€d of all itching when they were using this medication?A. Yes.

Q. And I am using the term "all" in particular.

A. Yes.

Q. Is that borne out by the clinical study, Doctor?

A. Yes (Tr. 1501-1502).

Q. Do you have an opinion as to whether Preparation H ointment or sup-positories wil heal hemorrhoids or piles?A. Well , I would assume from you(rJ usage of the word "heal" that you

mean have an effect upon acute inflammation or edema or some complicationof the varicosity and I would say yes (Tr. 1504).

Q. The symptoms that you have described are secondary, are they not, tothe hemorrhoid itself?

A. Right.

Q. Wil the application of Preparation H ointment or suppositories healthe hemorrhoid itself?

A. Do you mean heal the varicose vein?Q. Yes.

A. I don t think so (Tr. 1505).



Q. , . . Doctor , in your opinion , will Preparation H ointment or supposito-ries eliminate the problem of piles or hemorrhoids?

A. In the majority of the patients, for all practical purposes , yes, I thinkit will.

Q. It wiJ eliminate the problem?A. Most patients do not complain of the varicose vein itself unless it is tre-

mendously enlarged and results in prolapse or strangulation or some compli-cation of its being large. Most patients complain of _the complications of the

hemorrhoids, that is secondary infection , edema , swelling, thrombosis (Tr.1505-1506).

Dr. Burt, a Fe1Jow of the American College of Obstetriciansand Gynecologists , who delivered his 9000th baby during themonth of April , 1965 , testified that hemorrhoids are quite com-mon in women during pregnancy (Tr. 1514-17). In his regularpractice, in the treatment of these patients , he prescribes stoolsofteners and the use of suppositories. J n addition thereto , he ad-vises the assumption of a prone position by the patient frequently(Tr. 1522 , 1535). With reference to surgery, he stated (Tr.1521) :

A. I see very few cases , in my judgment , that it is necessary to go to thesurgical approach , except if one of the hemorrhoidal veins that's prolapsedbecomes, a thrombus or blood clot forms in them , then it becomes strangulated in the edematous and perhaps infection into those. That is a modifiedform of hemorrhoid. I refer those to the appropriate individual to, for the

most part just to have them enucleated , to remove that clot per se. That's asfar as I usually recommend.

Dr. Burt was shown a series of nineteen documents (RX5D-5K; 5W-5Z7), which identified the records of his patientsand which were utiized in the experiment in association with Dr.Young (Tr. 1524). Dr. Burt stated that, subsequent to the study,he has used or prescribed Preparation H in the course of his reg-ular practice (Tr. 1532). Based upon his clinical observations andas a result of the further experience he has had with the productsince the study, Dr. Burt expressed an opinion that PreparationH will , in patients during pregnancy or during the period imme-diately after childbirth , reduce the hemorrhoids in size (but thereis no assurance that they will not enlarge again), relieve the painand stop the itching due to hemorrhoids , and render the patientssymptom free until or unless the symptoms reoccur (Tr.1530-32). On cross-examination , we find this exchange;

Q. Nm. , Doctor, you stated that the presence of hemorrhoids in pregnantwomen ,vas due to mechanical factors based upon pressure caused by thegrowth of the fetus and the engorgement of the tissue surrounding the



uterus, and so on , plus the systemic flow of hormones to increase the blood

supply to provide suffcient nutrition for the fetus.Now , if aU of these things caused the hemorrhoids in the pregnant woman

how can the app1ication of a suppository to the patient's rectum change this?A. Sir , it doesn t change the situation that exists. It only relieves them of

temporarily relieves ihem of their symptoms, but it is associated with thecondition.

Q. Would you say, then , it does not cure the hemorrhoids?A. It does not cure the hemorrhoids (Tr. 1533-34).

Q. Do you consider lubrication to be the greatest benefituse of suppositories by one of your patients?A. No , sir.Q. What do you consider to be the greatest benefit?A. I think the combination of all of the factors of it.

derived from the

Q. Please continue.

A. Based on the fact that patients frequently wi1 resort-when otherthings are not available, at their disposal , at their home or place of abodetha t they wi1 resort to the use of vaseline or various creams or lotions , andthey have very little results.

But that is in comparison of what I have observed in my experience withthe use of the more medicated suppositories , which of course have a lubricat-ing type base with it (Tr. 1535 36).

Q. Doctor , you asked Mr. Murphy you answered Mr. Murphy s question

concerning your experience as to the effect of Preparation H , and stated thatyou felt that Preparation H would provide temporary relief in the reductionof hemorrhoids, that they would relieve the pain of hemorrhoids, that wouldstop the itch of hemorrhoids.

Now are you basing that conclusion on the 19 cases which you shared withDoctor Young?

A. Not entirely.Q. Well , what else are you basing it on , Doctor.A. On my experience with those cases, and those cases that, numerous

cases that I have had since that have used this particular preparation (Tr.1536-37).

Q. In response to a question from Mr. Murphy, Doctor, you stated thatyou felt that Preparation H would render your patient symptom free whilePreparation H was being used.

Now , did you mean free from all symptoms?A. As I recall , I t.hink he categorically asked me about it broken down in

various specific symptoms. I don t think there is any drug that at al1 times

wi1 relieve all symptoms , to my kno\vledge (Tr. 1538).

Q. Do you feel that Preparation H suppositories wil cure varicosities ofveins of the hemorrhodial plexis?



. It wil not cure the varicosities. It win cure the secondary symptomsthat go along with it.

Q. Is it your testimony, Doctor, that Preparation H suppositories will in

your opinion relieve all pain in your patients'?Now, I want you to take particular note of the word "all " and I am speak

ing, of course , of pain attributable to or caused by the hemorrhoids?A. An is a pretty inclusive word, and I don t think you can say all pains

but the usual pain associated with hemorrhoids it will give symptomatic

relief.Q. I don t think you have answered my question , Doctor.A. Will you rephrase it for me , please?MR. MAC MAHON: Would you read the question back , Mr. Reporter.(\Vhereupon the reporter read the question back.)

THE WIT1\ ESS: Xo , it won t relieve all of the pain (Tr. 1540-41).

Q. Excuse me , Doctor , I am limiting my quesUonto or caused by piles or hemorrhoids?

A. It wil relieve itching:

Q. All of it?A. In my observations it has (Tr . 1542),

to itch that is attributed

Q. , . . Do you have an opinion as to whether Preparation H suppositorieswill heal , cure . or remove piles or eliminate the problem of piles in your pa-tients?

A. It will alleviate or relieve most of these situations if there is nothingmore basically undermining or producing them , pure symptomatic ones.

Q. ""Vould you say that this was temporary relief of minor symptoms?A. It wil give temporary relief from minor symptoms (Tr. 1542).

REDIRECT EXAMI" A TION

Q. As a doctor, sir , when you use the phrase " relief symptoms " or similar

phrases , what do you mean to convey-do you mean that the patient' s symp-toms are cleared up?A. Yes , sir.

THE \VITNESS: Their complaints (Tr. 1546).

Dr. Epstein specializes in internal medicinc and gastroenter-ology, and is Assistant Clinical Professor of Medicine at theGeorge Washington University School of Medicine. He was for-merly "a new Drug Offcer" with the Federal Food and Drug Ad-ministration. In the course of a usual year in his practice , he seesand treats between 40 and 50 hemorrhoidal cases. In the eightyears that he has been in practice , he has referred possibly 10 pa-



tients for hemorrhoidectomies. With respect to cases not referredto surgery, he describes his method of treatment as fol1ows (Tr.1555) :

A. I use the standardly recommended , conservative medical measures. I usea hemorrhoidal suppository, and sometimes a hemorrhoidal ointment. I instrnet my patients to take care with their diet, with respect to the avoidanceof constipation, the avoidance of highly spiced foods , and alcoho1. And I alsoimpress upon them the necessity for careful anal hygeine.

As to the results he has been able to achieve with this kind oftherapy, he said (Tr. 1555-56) :

A. I think my results probably fall in generally with those of my col-leagues. "' e get uniformly successful results with conservative medical man-agement in mild to moderate hemorrhoidal disease.

Q. And in speaking there of mild to moderate hemorrhoidal cases are youspeaking general1y in terms of that type of hemorrhoidal disease which in

your opinion does not require surgery or surgical treatment?A. I think that is a fair statement.

Sometime during the latter part of 1961 , he was contacted byDr. James Kelly of Whitehal1 Laboratories , and agreed to under.take a clinical investigation of Preparation H. Dr. Kelly wantedapproximately a hundred cases , and , as Dr. Epstein felt that hecould not supply such volume within a reasonable time , he madean arrangement with Dr. Norman Isaacson to carryon a parallelexperiment , with each doing his work indcpendently. Dr. Ep-stein s study involved 33 subjects who were patients in his pri-vate practice. A patient selected for the study, with his consent

was told that the doctor was evaluating some hemorrhoidal prep-arations which were completely safe , but the patient was not in-formed as to the name of the drug. The product used in the studywas packaged in plain , white containers on which there was alabel which stated that they were hemorrhoidal suppositories orhemorrhoidal ointment, with directions for use , but there was noidentification as to its marketing name. On the first visit , the pa-tient was put on the doctor s usual , conservative program hereto-fore described , using Preparation H as the medication involved.The patient was instructed by the doctor to use the preparationmorning, evening, and following each bowel movement. Arrange-ments were made with respect to return visits by the patient. Onthe first and each subsequent visit , the doctor examined the pa-tient and noted on the patient's chart his observations , togetherwith the patient' s complaint , which information was set forth ona case report form (RX 6A-6Z7). Such records show that each



patient made either two or three visits after the initial examina-tion , usually about a week apart. Only one subject involved in thestudy was referred to surgery. Since the conclusion of the investi-gation , Dr. Epstein has prescribed Preparation H for some of hishemorrhoidal patients in the regular course of the conservativetherapy which he employs. Based upon the investigation and hissubsequent experience with Preparation H , Dr. Epstein expressedan opinion that "it is an effcacious agent in the conservative man-agement of patients with mild to moderate hemorrhoidal dis-eases" (Tr. 1569), can reduce hemorrhoids in size, wil relievepain where pain is present as a symptom , can reduce edema, or

swellng, or inflammation where they are present, and can rendera patient's asymptomatic hemorrhoids symptomatic free with thisqualification (Tr. 1571) :

A. When you say symptom free , it is merely the amelioration of the symp-toms that the patient came in complaining of. This does not of cour(sJemean that I have cured the disease.

On direct examination , he testified (Tr. 1572) ;Q. J\T , I will ask you , Doctor , whether , on the basis of your clinical inves-

tigation , plus your general education, training and experience, you can ex-press a vie'.v as to whether Preparation H alone and without the conservativeadjuncts involved in your program , would have the same beneficial effect onsymptomatic hmorrhoids as you have testifled it would have as part of yourconservative program'?

A. I think that this is a fair assumption to make.

The witness was subjectedreading in part:

Q. Did you indicate to the patient involvcd in the study) in any waythat you thought that he might obtain some benefit from it'?

A. Only \vhat he might have been able to gain from his own thinking fromthe standpoint that I told him that this was a popularly used hemorrhoidalpreparation.

Q. Do you think that this would have a psychological effect on the patientif he knew that this was a popular , broadly used preparation , that he wouldfigure , well , if it is widely used and well-known , it must be good , do you thinkthis effect would take place?

A. I don t think that that is really a signiflcant attribute in a situation like

this. I realize that outside of these hearings you don t have a lot of personalexperience with patients who have hemorrhoids. But these are people who arequite uncomfortable , and if they arc uncomfortable they arc going to let youknow about it , and if what you give them does not help, they are going to letyou know about it , and then want something else. Because this is somethingthat can make your life miserable (Tr. 1577 78).

to substantial cross-examination



Q. But at the same time you admit, do you , Doctor , that knowing what thedrug is and knowing that every patient is getting the same drug would havea tendency to bias you in favor of the drug that ,vas being used?

A. I don t kno,,.' whether that is a fair statement on your part , sir , becauseI think we try to approach any of these studies with an unbiased attitude.There is no point in me or anyone doing clinical investigations , if you aregoing to merely turn Qut testimonial. I think it is more important to knowwhether an agent does not work or whether it has problems \\'ith side effectsand the like than it is to kno,v whether the drug is basically effcacious (Tr.1580) .

Q. So that you would say that this study that you did on Preparation Hwas not the best type of scientific approach , is that right?

A. This is again a diffcult question 1:0 ans\ver. I think it is diffcult for youto answer it as ,veIl. As far as the study itself is concerned , the technique

that we used with this study was a matter of evaluation of ,vhether the drug'vas effcacious in this particular type of patient. This is 'vhat we were askedto determine , and we did this in an unbiased fashion.

You also must take into account that any study and the one that you wi1hear about later were done with private patients. And I have a responsibilityto my patients to make him comfortable. And if I felt that the agent that Iwas using ".!uId not help render him comfortable I don t think ,ve would

have gone into this (Tr. 1581).

Q. Doctor , do you f('el thai the patients would have had any bias with re-gard to the results that they reported to you? Would you think that the pa-tients v,.'uld be anxious to come up with positive findings , since they weretrying something new?

A. I think that the patients would only be anxious to come up with an im-

provement in their problem. They don t have to satisfy me from this stand-point (Tr. 1583).

Q. You have done clinical investigations of work beforc , havp you not?A. Yes.

Q. And you 113ve undoubiedly prepared yourself for that by reading in thefjeld , is that right?

A, I have read in the fjeld , yes.Q. And in your readil1gs have you come across any data or studies or re-

ports of the psychological effect that I am speaking of?A. Yes , these things appear in the literature , I think , with regularity with

people \vho write review articles with respect to clinical investigations. Butthis is a very diffcult thing to measure. And this is such a diffcult entity toassay.

Q. Vlithout measuring it do you feel that it existsA. In all likelihood it does (Tr. 1584-85).

Q. And , Doctor, you stated that in your opinion hemorrhoids includes the



whole picture. Now , by that do you mean the perivascular tissue that sur-round the dilation or varicosities that constitute the hemorrhoids.

A. I think that it is very diffcult from a clinical standpoint sir , to merelysay that hemorrho ids are the dilated vennI or the varix, when most peoplediscuss hemorrhoids they are talking about a clinical entity. That is what theatients tell you what is bethering them , plus what the physician has the op-

portunity to observe.

Q. But as a physician do you not consider that the varix and the edema,the i'nvelling, and so forth , are secondary, they arc two separate disease enti.ties or three separate disease entities?

A. 1\0 un1es5 we are having differences in semantics here. I think thatthe hemorrhoid-the peri-hemorrhoidal inflammation, the swelling, theedema , the evidences of infection , are all basicCalJly part of the same clini-cal entity. (Tr. 1593).

A. My training and medical , personal medical philosophy, leads me toa\vay from in.iection therapy. r try to avoid it if I can.

Q. Do you refer patients for injection therapy?A. I personally, have never done so (Tr. 1595).

steer

Q. You stated on direct testimony, DoctOT, that your method of treatmentthat you described as being a conservative method v.rs the standard , recom-mended treatment. Kow , whose standard and who recommended it?A. Well , I think that is not a pl"ject of my own thinking, this was what

you get from reading medical literature with respect to the conservativemanagement of hemorrhoidal disease. For example , if you pick up Eddie Pal-mer s text of clinical gastro-enterology you wiD find that he states that avery high percentile of hemorrhoids are amcanable to conservative therapy(Tr. 1595-96).

Q. In your opinion has this program of therapy produced any cures ofhemorrhoids?

A. Mr. McMahon , there is on1y onc way to cure hemorrhoids.Q. And what is that , Doctor?A. And that , sir , is to remove them surgically.I would like to elaborate a little further along those lines , because I think

it is germane to the present discus:;ion. When you say " cure" you are merelyreferring to the situation as it exists today. This docs not mean that the sur-gical removal of hemorrhoids today will prevent the patient from developing

the disease in the future, because according to thc experts in this field-and Idon t pass myself off as an international expert by any manner of mean5-but according to the experts , there is a high incidence of recurrence of

tLhJis disease (Tr. 1597).

Q. In relating your subsequent experience with Preparation H and bysubsequent" I mean since the study- you indicated that you used Prepara-

tion H with some patients. Can you estimate how many patients you haveused this with?



A. I would venture to say this might b:; in the neighborhood of possibly tento 30 morc.

Q. And what other medications of this type do you prescribe , that is , oint-ment or suppositories?

A. I occasionally use Wyanoid , Anusol , and rectal Medicone-I use , for ex-ample, in getting the patients samples in the offce , that product 'which mightbe currently present that the detail man left , which aids the patient as wellnnancially (Tr. 1608).

Q. In response to a series of questions from Mr. Murphy eliciting youropinion as to the effcacy of Preparation H in several categories , you statedthat it had been your experience that ' Preparation H did reduce hemorrhoidsin size, is that correct, Doctor?

A. I think that is substantialJy correct, yes, sir.Q. :'aw, how would you account for this reduction in size?A. I think the reduction in size is due to the elimination of secondary prob-

lems, the protective effect that the liver oil adds , possibly to the ability of theBiodyne to affect the metabolic activity of the local tissue , as well as the factthat there is time as an intervaL

Q. Now , first of all , Doctor , you arc assuming, arc you, that the effect of

the Biodyne or shark liver oil would cause this reduction in size?A. I think the reduction in size is primarily the nature of the body s heal-

ing process , sir , which 11as been aided and abetted by the therapy.Q. Wouldn t the same thing happen if you let the hemorrhoid alone?

A. That is conceivable. I don t know whether it would happen as rapidly oras simply. That is a very diffcult question to ans.wer.

Q. You mentioned the factor of time , Doctor. Would you say that this is ofequal importance with the ointment or the suppository?

A. Again , this is diffcult to quantitate , because some patientsimprove. Some patients will improve in time on a program ofany other similar type of conservative program (Tr. 1612-13).

in time don

this type , or

Q. If it is the nature of the hemorrhoids to corne and go , you mean thatthis wil occur spontaneously?

A. This can occur spontaneously, and it may not occur spontaneous1y. AndI think all therapy in medicine is merely aimed at aiding the body with itsown healing processeCsJ. I don t think anybody who practices medicine saysthat " My treatment is solely responsible for your improvement " it is a mat-ter of aiding and abetting a \-.1-lOle picture. You treat the patient, sir , as awhoJe , and not as a single disease entity ('fl'. 1613- 14).

Q. What does Preparation H do that cause the pain to be relieved?A. I think it Tf duces some of the inflammation and infection.Q. And how does it accomplish that , Doctor?A. By its protective action on the area, and possibly by cutting out the

infectious element, and by protecting it with its oily base , the entire gamutof what is purported to be the therapeutic effect of the ingredients.



Q. What is purported to be the effect of the therapeutic ingredients , is thatwhat you said , Doctor?A. Yes , sir.Q. But not what you know of your own personal knowledge?A. I think I have said so to that effect.Q. Again your opinion is based on assumption , is it not?A. And my own observations , sir.Q. But your observations simply show the results?A. Yes (Tr. 1616-18).

Q. You stated , Doctor, that it was your opinion that with the use of Prepa-ration H alone , and 'without the conservative adjunctive therapy that youusually prescribe , that you would obtain the same benefits in your patients ashad been obtained with the conservative therapy, is that right?

A. I think that this is a fair statement to make (Tr. 1620).

Q. My question is this , Doctor. Then why do you prescribe this conserva-tive adjunctive therapy?

A. Because anything that you can do to aid and abet a patient's rapidityof improvement to remove annoying other problems is just an extra addedattraction in getting a patient to feel better more rapidly, sir.

Q. But if you are going' to achieve the same result with Preparation alone , why bother the patient with the other procedure?

A. We are going into the matter of medical pllilosophy nmv. And I thinkthe philosophy is that if you feel that there is some etiological factor involved

you try to remove the cause as ,veIl. For example , if perchance I treated apatient-and this is strictly hypothetical now-jf perchance I treated a pa-tent with hemorrhoidal disease whom I felt had hemorrhoids strictly as theresu1t of poor bo,ve1 habit and chronic constipation, I would treat the hemor-rhoids. And at the same time I would make every effort to get the bottom ofthe bowel habit problem so that he could ameliorate this , specially with res-pect to the future , because as we both have discussed before, and \ve bothagree , this is a disease that can recur with rapidity and regularity (Tr.1620-21) .

Dr. Isaacson, a general surgeon with a "special interest inProctology," is certified by the American Board of Surgery. Inaddition to carrying on his private practice, he is a C1inical In-

structor in Surgery at George Washington University MedicalSchool. He sees between 150 and 200 hemorrhoid cases in a yearand he estimates that between two-thirds and three-quarters ofthose patients come to him on referral from other physicians (Tr.

1651-54). As to those that come from other physicians , he testi-fied (Tr. 1654) :

A. Under two circumstances-those that come from general practitionersor internists who "muld come after they have been tried on a conservative



regimen , and then referred to me for either continued care or surgery. The

others wou1d come from specialists who are in a limited field , such as earnose and Unoat man , cardiologist , ,yr1O would not undertake the care of hem-orrhoids even from its initial onset , and those \Vou1d be referred to me di-reet1y.

About one-third of his cases are subject to hemorrhoidectomies.In terms of severity and complications , he assumes that the caseshe sees and treats are probably a litte more severe comparedwith the cases a general practitioner or internist is apt to see (Tr.1654). As to the type of hemorrhoid cases in which surgery is theindicated method of treatment , he said (Tr. 1656) :

A. Tll€ patient who, because of severe bleeding, comes in with a significantanemia , that patient should nave surgny. A patient who has a conditioncaned srangulated hernorrhoid , in which the hen:orrhoid , particularly inter-

nal henwrrhoic!s , has prolapsed througl1 the sphincter muscle , grasped by themuscle , and its Yf'turn fto'v impeded , and WllO is in imminent danger of get-ting gangrene of fhe hemorrhoids. A patient ,vno has a significant amount ofprolapse of his hemorrhoids , in which they pu;.h out , either requiring manualimpIaccment at the time of a bowel movement or ,vhieh are irreducible at thetime of prolapse , should be subject.ed t.o sUl'gel'

The patient who comes in with a large thrombosed hemorrhoid usually has

offce snrgery. A thrombosed he!l,orrl'oid is a clot within an external varixjust. beneath the skin , and this can usually be evacuated and give the patientsymptomatic relief'

Beyond this, the indications for surgery beco1JH' nebulous. If you cannot re-lieve symptoms by othej' methods , or relieving symptoms , have the patientcome back repeatedly witl, recurrences, then these patients should probably1,ave surgery.

With reference to treatment of the two-thirds of hiswho do not havc surgery, Dr. Isaacson said (Tr. 1656-57)

patients

A. Wel1 , they are given dietary instructions , they are taught to avoid

spices and ,;lcohol

, ,,'

hich ,viJj irritate the rectum on evacuation . They areusually given a bowel softener , such as mineral oil or colase , which keeps thebowel J'elatively soft. They are Kiven Sitz baUls , which consists of soaking ina hot tub of water two oj' three t.mes a day and they arc usually given alocal ointment or suppository.

As to the effects of such therapy, he says that "ApproximateJytwo-thirds will get symptomatic relief , at lcast for a time " and

that such treatment cnn succeed in avoiding the need for surgicaltreatment

, "

at Jeast temporarily" (Tr . 1657). In 1961 , throughDr. Jerome Epstein , he agrced to participate in a clinical investi.gation of Preparation H. He identified RX 6Z8 through RX 6Z93(eighty-six cases) as the forms filled out by him of the subjectsinvolved in the study. When a patient was seen , the doctor s ob.



servations or remarks \vere entered on the patient' s chart , whichwere later noted on the form (Tr. 1663). On the initial contactwith the patient in the course of the investigation , the patientwas put on a bland diet and given a bowel softener. The patientwas supplied with the ointment or suppositories in containerswhich did not reveal the name of the product. There were printedinstructions on the tubes or boxes as to the use of the productand, in addition , the patient was told verba1ly to apply it morn-ing, evening, and after each bowel movement (Tr. 1662). The pa-tient was also told that this ointment or suppository was reportedto be pretty good (Tr. 1661). The records show that eaeh subjectwas treated two to four times fol1owing the initial visit, suchvisits usua1ly being spaced three to seven days apart (RX6Z8-RX 6Z98). Twenty-six of the eighty-six patients employed inthe study required hemorrhoidectomies. Since the conclusion of

the investigation , Dr. Isaacson has used Preparation II in hispractice. Based on the study and subsequent experience, Dr.I saacson expressed the opinion that Preparation H " is a safe andeffective remedy in the treatment of mild and moderate hemor-rhoids and can render the patient symptomatic free after localapplication " and that it can relieve pain where pain is present as" symptom of hemorrhoids (Tr. 1667). As to whether Prcpara-tion H wi1l reduce hemorrhoids in size, he stated (Tr. 1668) ;

A. A hemoTl'hoid is a varicose vein , and because of secondary edema ands"\vplling: and intlammation they increase in size due to that. The applicationof PrcparatiOJI H can reduce the secondary swelling', fhe secondary edemaand inflammation. It cannot reduce the size of the "hemorrhoid and no prepa-ration , I believe , can except surgery.

To the question

, "

When you are treating a patient for hemor-rhoids, Doctor, do you find that )'OU are required to treat onlythat dilated 01' varicose vein , or are you called upon to treat ahemorrhoids as a complex of things ?" , he replied (Tr. 1668) :

In most cases , you Rre treating the C'omplex , or the secondary inflammationof the hl'morrholcl. Probably the ma.iority of people ove!' the age of 20 havehemorrhoids , and yet by tl1e same token , the majority of people are not symp-tomatic from these hemorrhoids.

Dr. Isaacson testified that prim' to the study he had the opinionor impression that Preparation II "was no good" (Tr. 1659), andhe explained the basis of such an opinion: "I think that I was

seeing the patients who were faHur€s with Preparation H, just aswe had failures in this study" (Tr. 1667). Dr. Isaacson also said

1578 FEDERAL TRADE COMMISSION DECISIOXS

70 F.

that he had hemorrhoids , and for their treatment

, "

Lately I have

been using Preparation H" (Tr. 1670). On cross-examination , thewitness testified:

Initial Decision

Q. Considering the procedure and protocol that was employed in this pre-sent test , and on the basis of your experience in these two previous studies,pIULS) what you have just said regarding double blind studies, do you con-sider this test of Preparation H in which you participated to be a valid scien-tific study?

A. I believe you can form an impression from the study, as I have. Hadthis been a double blind study, the impression of course would have been onfirmer ground.

Q. Wel1, do I take it , then , Doctor, that your testimony is that despite theconclusions which you have expressed , that you do not consider them to be

based on real firm ground?A. I believe that on the basis of this study I CRn form an impression , as I

have , and I have actually recommended to the company that a double blindstudy should be performed to eliminate the variables.

Q. SO you fecI that this study had deficiencies , js that correct?A. Yes , sir.Q. And making it a double blind study, would this be the only change that

you would suggest if you were to devise a proccclure?A. Yes. There might be a few minor changes in the protocol , but this

would be the major chang'e that I 'would make in an investigation of thisdrug.

Q. No\v, in telling your patients about the use of the ointment or supposi-tories that had been furnished to you for this test , you did not tell them thatit was Preparation H, if my notes are correct.

A. T did not.Q. You did say, however--if I am not mistaken-that it was reported to be

pretty good.

A. Yes , sir.Q. Do you feel that this had any influence in terms of a psychological ef-

fect on the patients?A. I think it' s possible.Q. Did you see any evidence of that?A. I \vou1d not know what evidence would indicate to me that this was a

major factor ('11'. 1673-74).

Q. Do you feel , Doctor , that with a bowel softener and a Sitz bath takenfrequently, and diet , that if this treatment ' were supplemented by any emol-lient or lubricant type of ointment or suppository that you could achieve thesame results that were achieved here ..vith Preparation H?

A. Are you talking about similar preparations or are you talking aboutjust a bland vaseline?

Q. Well , let' s start 'with the vaseline.A. My impression vmuld be that it would not. I think that hemorrhoids

given diet, a bo\vel softener, Sitz baths , ..vil in time become asymptomaticwithout the use of any preparation. I would not expect the subsidence of



symptoms to be quite as rapid as it was with the use of Preparation H in thisstudy (Tr. 1675-76).

Q. Doctor , you have used the term " impression" several times. Now , wouldyou differentiate for me , please, between your Use of the word "impressionand your use of the word "opinion

A. An impression is an intelligent opinion. For instance , if you come intome with a variety of symptoms , I can make an impression of your diagnosis.I can prove that diagnosis with a series of tests. For instance , if you come tome with upper adominal pain , particularly after eating, my impression isthat you have an ulcer. That' s an opinion. When I confirm this with an X-rayof your stomach , that you have an ulcer , I now have a diagnosis.

By the same token , in this study I can onJy give you an impression , sincethere was not a control study, as you pointed out. These patients were giventhe ointment. On the basis of my previous experience with a similar type ofcase , I achieved results that I thou,tht were superior than no treatment orwith just diet and mineral oil alone.

Had I a1ternateJy given patients , say, simply a suppository of no therapeu-tk result , and achieved significant differences, then I would have a muchfirmer conclusion , rather than just an impression.

Q. Well , now , in response to ::11'. Murphy s series of questions , so1iciting

your opinion , were these firm opinions , Doctor , or were these impressions:A. These are firm opinions (Tr. 1676-77).

Q. . . . You stated that it was yom' opinion , then, that

would rclieve pain associated with symptomatic hemorrhoids.A. That's correct.Q. How do you explain this affect, Doctor:

Preparation H

THE WITNESS: I cannot explain it. I canobtained. In a certain series of cases , as I can

86 cases , there was relief of pain (Tr. 1678).

only tell you thc results wesee by read(ingJ over these

Q. Well, then, Doctor, is it your opinion that the activePreparation IT are responsible for the rapidity of the relief?

A. I would have to say yes ('fr, 1678).

ingredients in

Dr. Berkowitz, a physician specializing in gastroenterology, isan Associate Professor of Medicine at Hahnemann Medical Col-lege, attending Chief in Gastroenterology at the Albert Einsteinand Sidney Hi1lman Medical Centers in Philadelphia , and a mem-ber of the Board of Internal Medicine and Gastroenterology. In

addition to his medical degree , he has a Master of Arts in bioch-emistry and a Master of Science in biochemistry (RX 76A-G; Tr.1075-1080). In the course of his practice , he has maintained hisinterest and experience in biochemistry, and several of his cur-



rent projects are concerned with biochemical studies. Recently hewas elected as a mem ber and a Fellow of the American College ofClinical Pharmacology and Experimental Therapeutics. Dr. Ber-kowitz said the requirements for such an election were (Tr.1078) :

A. .. You have to have first completed certain professional requirementand secondly, you have to have been actively engaged in and published meri-torious works in the general field of clinical evaluation. (RX 76A-G; Tr.1075-1080.

He estimates that he sees annually between 200 and 250 pa-tients who have active symptoms of hemorrhoids , and during thepast year he has referred four or five patients to a proctologist orto a general smgeon for the reason that the patients needed sometype of treatment other than what he could do conservatively(Tr. 1080-82). As the principal symptoms and signs of hemor-rhoids , he said (Tr. 1082-83) :

A. Wen , I think tIle principal symptoms and signs are pain , bleeding, itch-ing, spasm , problems with ddccation , and varion:: types of feelings , such aspressure in the l'CctUH1 , or a bearing down sensation in the rectum , and possi-blya discharge may be a symptom.

The sip:ns of hemonhoids fhat I would see would be evidences of the hem-orrhoid itself , evidences of spasm, evidences of discharge , of spasm, andevidences of the results of itching.

As to the treatment employed by

rhoid problems , he said (Tr. 1085) :him of patients with hemor-

\Ven , first I try to correct any precipitating cause that I can find. For ex-ample , jf they have diarrhea , I try to treat their diarrhea. If they are consti-

pated , I try to im.provc their bowrl habits.Secondly, I prescribe good anal hygiene.

Thirdly, I would prescribe the use of Sitz baths , and fourthly, I wouldprescribe tlw use of S01'ne local J'edal rnedication , either ointment or supposi-

tories.

He explained the results of such treatment (Tr. 1086) :

WelJ , r haw ;lchieVfd excclJcni l'esults as eviden('ed by the fact that I haveonly found it necessary to refer a few people to-for surgical treatment.

Through discussions had with Mr. Basil Candon , Assistant tothe Medical Director of Whitehall Laboratories, Dr. Berkowitzundertook and performed a clinical study of Preparation H ('11"1087). Mr. Can don , who has a YIaster of Science degree in thefield of Histology and Physiology, testified that Dr. Berkowitzwas requested to undertake the study of approximately 100 cases



in August of 1963, which was designed as a double blind evalua-tion of Preparation H

, "

a technique in which neither the investi-gator nor the patient knows the specific drug that he is receiv-ing," which "has been employed to eliminate bias on the part ofthe patient or on the part of the physician in charge of the study(Tr. 1040-41). The products employed in the study were Prepara-tion H ointment and Anusol Vnguent , and preparation H supposi-tories and Anusol suppositories (Tr. 1041). As to why Anusolwas used in the study, as well as Preparation H, he explained

(Tr. 1041-42) :

On the basis of experience in setting up clinical studies , we frequently usea reference drug for comparative purposes and we selected anusol on thehasis of an independent marketing report \vhich is provided us at regular in-tervals , which indicated that anusol was the most-was the drug most widelyused by physicians- used or recommended by physicians for the treatment ofanorectal diseases.

On cross-examination Mr. Can don further explained the basisfor the use of Anusol as a comparative product (Tr. 1053) :

WelI , standard procedure in recent years in the evaluation of drugs-a ref-erenc e drug is usually used. Now , that reference drug may be a placebo or itmay be an active drug. There is a school of thought that believes that the USe

of an established activ-e drag as a reference drug is much more meaningfulthan using a placebo.

The products sent to D,' . Berkowitz and used in the study werein plain containers so as not to reveal to the doctor or the patientsthe name of the drug contained therein. However, there wasnoted on each package a code number which would serve to iden-tify after the study the product given to the patient. The key tothe code number was contained in a document (RX 7-Z267)which was sent to Dr. Berkowitz "not to be opened (until thestudy was completedJ except in an emergency" (Tr. 1044). Dr.

Berkowitz knew that the products to be used in the study werePreparation Hand Anus01 , but he was not given any informationas to the identity of each individual package (Tr. 1042-1045).Mr. Can don identified RX 7 A through RX 12267 as the reports Dr. Berkowitz on 96 patients involved in his study. The followingeight tables are a compilation of the results appearing on themiddle of the first pages of the report forms of Dr. Berkowitz forthe patients treated with Preparation H. The responses indicatedon the final examination of these patients during the study wereused. Identification of the cases in which Preparation H was usedis made by reference to the key for the study, RX 12267. The re-



port forms for the patients treated with Preparation H used forthese compilations and tables are: RX 7D , 7P , 7S , 7V, 7Y , 7Z27Z11 , 7Z22, 7Z25, 7Z28, 7Z40, 7Z58, 7Z61 , 7Z67, 7Z82, 7Z887Z91, 7Z94, 7Z99, 7Z101 , 7Z106, 7Z108, 7Z111, 7Z117, 7Z1237Z126 , 7Z132 , 7Z140 , 7Z145, 7Z147 , 7Z154, 7Z156, 7Z161 , 7Z1697Z178 , 7Z181 , 7Z183 , 7Z185 , 7Z191 , 7Z199, 7Z201 , 7Z208 , 7Z2117Z213 , 7Z215, 7Z220, 7Z223 , 7Z236 , 7Z239 , 7Z241 , 7Z249, 7Z2527Z261. The report forms of two patients given Preparation H, butwho did not return for subsequent examination and observation

(7Z158 and 7Z196) were not included.

TABLE 1. NUMBER OF CASES IN WHICH RELIEF WAS AFFORDED

Percent- Percent-No. of No. of ageo! age of

NO. ca.ell case" case8 casescalles lchcre where 110 1chere where no lvhere impTove- improve- improve- improve-

S)lmptom presented ment ment ment ment

7.4%Pain 92.Spasm 92.Bleeding 93.Discharge 85. 14.Protrusion 92.Edema I 92. 7.4%Pruritus (Itching)

TABLE 2. RELIEF OF PAIN: Grades of Resp()')'", to Treatment

Grrlde of ResponseNumberof Callell

Per Centof Total

" A" Excellcnt-completeGoodFairNo ChangeFailure

remission

Total

72.

11. %

TABLE 3. RELIEF OF SPASM.' Grades of Response to Treatment

Numberof Casel!

Per Centof TotalGrade of Respon8e

A" -Excellent-ompleteGoodFairNo ChangeFailure

remission

Total

73.

11.5%



TABLE 4. RELIEF OF BLEEDING.' G7'ades of Response to Treatment

Numberof CaBCB

Per Centof TotalGrade of Response

remissionA " Excellent-completeGoodFair

DJJ No ChangeFailure

Total

77.

12.

TABLE 5. RELIEF OF DISCHARGE: Grades of Response to Treatment

Grade of ResponseNumberof CaBea

Per Centof Total

A " Excellent-completeGoodFairNo ChangeFailure

Total

71.4%

14.

remission

TABLE RELIEF OF PROTRUSION: Gmdes of Response to Treatment

Number Per CentG7ade of Responsc of CUBeB of Total

Excellent-cornplete remissjon 64.Good 15.Fair 11.8%No ChangeFailure

Total

TABLE 7. RELIEF OF EDEMA.' Grades of Response to TreatmentmbeT

of CasesPer Centof TotalGrade of Response

remissionA " Excellent-completeGoodFairNo ChangeFailure

Total

74. 1'l'7.4%

11.1%7.4%

TABLE 8. RELIEF OF ITCHING (PRURITUS): Grades of Responseto Treatment

Grade of ResponseNumberof CaBes

Per Centof Total

Excellent.complete remissionGoodFairNo ChangeFailure

Total

73.

12.

1584 FEDERAL TRADE CO:lMISS!OK DECISIONS


The reports of Dr. Berkowitz in the instances where Anusolwas used as the medication show that results obtained were simi-lar to the results indicated by the foregoing tables. Dr. Berkowitztestified (Tr. 1091) :

The protocol was set up in such a way that 50 patients would he treatedwith a suppository, and 50 patients '\'.Quld be treated with an ointment , andthe medication was to be dispensed in random fashion , the patients were to beinstructed as how to take the ointment or the suppository. Their other medi-

cations , if they were taking them , were not to be changed. And there \vculdbe no gross departure from anything that they were doing.

In a11 , he studied 105 patients , but , because 9 patients did notreturn after the initial visit, the results were given on 96 patients(RX 7 A-RX 7Z266). Of this number , 54 were treated with Prep-aration H suppositories or ointment. The study took approxi-mately fifteen months , and was completed in December 1964 orJanuary 1965 (Tr. 1091 , 1102). The patients came from threesources: His private practice , the Sidney Hi11man Medical Centerand the Albert Einstein Medical Center (Tr. 1092). As to thestandards he employed in selecting a patient for the study, said (Tr. 1092) :

First of 0.11 the patient must have had hemorrhoidal disease that wassymptomatic enough to require treatment. And secondly, the other qualifica-tion was that he had to be a patient that I thought \vas intelligent enough to

follo\v instructions. And thirdly, that I thought would come back.

The patients were not told that they were a part of the study.The record shows that in practica11y all instances the patients

were examined by the doctor two to four times after the initialvisit , the last visit usually coming the fourteenth day after theinitial visit. Dr. Berkowitz stated that the suppositories and oint.ments sent to him and used in the study were in plain cartonseach bearing an identification number , but that there was nothingto indicate which was Preparation Hand wh)ch was Anusol (Tr.1089-1090). He also testified that the key for the study (RX7Z267) was sent to him in a sealed envelope, and it was not

opened prior to the completion of the study. On the basis of theobservations that he made in the course of the study, Dr . Berkow-itz testified as follows:

. . . a significant improvement in both subjective signs and objective find-ings \vere produced in any.where from 84 to 91 per cent of the patientsrtreated with Preparation HJ (Tr. 1112).

. . Preparation H ('an certainly reduce the size of hemorrhoids (Tr.1112-13),



treatment with Preparation H was effective in reducing pain in thevast majority of patients who had pain (Tr. 1113).

. . . it was my conc1usion that treatment with Preparation H could defi-nitely render the primari1y initially symptomatic hemorrhoid to a statuswhere it was no longer a problem (Tr. 1113).

There is no doubt in my opinion that a good percentage of the patients that

I saw initially, prior to treatment , would have been treated surgically hadthey been seen initially by surgeons (Tr. 1114).

. . . it was my impression that the vast majority of patients with itching asa symptom of symptomatic hemorrhoids had their itching relieved (Tr. 1114).

. it was my conclusion that Preparation H treatment was effective inreducing edema in the vast majority of patients treated (Tr. 1115).

When asked whether Preparation H would effect any reliefother than the reJief of minor pain or minor itch , Dr. Berkowitzreplied (Tr. 1115) :

Yes , sir. The patients used in my study all had major pain or major itch asa prerequisite, and if their symptom:; \vere only of a minor nature , they werenot included in the study.

On cross-examination, Dr. Berkowitz testified in part:Q. Doctor, you stated that you had concluded , following this study, that

Preparation H reduces hemorrhoids in size. V,Tould you explain how you cameto this conclusion?

A. Yes sir , I could see it. You can see the size of a hemorrhoid , and youcan see whether it is bigger or smaller.

Q. Well , now , you would see a patient , we wil say, today, and not see himagain for a week. How did you record the size of the hemorrhoid the firsttime as opposed to the size the second time? Did you measure them?

A. This was a visual impression , based on my experience as to the degreeof improvement in size (Tr. 1128 29).

Q. Isn t pain a subjective symptom?A. Yes.

Q. And what is painful for me may noi be painful for you?A. That is exactly right.Q. SO that you are entirely dependent on what the patient tells

whether the pain has been relieved or not , is that not so?A. Yes (Tr. 1129-1130).

you as to

Q. And if he left the hemorrhoids alone completely in a period of timewouldn t the pain go into remission spontaneousJy?

A. \Vell , I cannot answel' that , because it has not been my custom to justcasually observe people with symptomatic hemorrhoids and do nothing aboutit. So I know of no study like this. But I do think that even with no treat-ment, if they were to get better , it would sure take them a much longer timeto get better (Tr. 1130).



Q. Now, you also stated that you had concluded that Preparation H wouldcause hemorrhoids to cease to be a problem . Now, did you mean that literally,Doctor?

A. Yes, sir.Q. That once they have used a course of treatment of Preparation H, that

they are free of their hemorrhoids , and they wil1 have no more problems? Isthat what you mean?

A. I did not say that exactly, sir. I said that I have seen people with symp-tomatic hem6rrhoids that I have treated , that I have seen again three

months, six months , a year later , who have no further problems.Now, 'whether they wil have problems a year from now or two years or

five years from now, I cannot say.Q. Are the hemorrhoids stil there?A. If you look for them , you wil fmd a small hemorrhoid, yes.Q. SO that you have not actually cured the hemorrhoid, have you?A. No , sir, I have not cured the hemorrhoid. I doubt if you can ever cure a

hemorrhoid , except by removing it (Tr. 1132).

Q. Do I take it, Doctor, you are opposed to hemorrhoid surgery?A. No, I think that hemorrhoid surgery is definitely indicated in certain

conditions. But I am opposed to hemorrhoidal surgery in patients who can betreated medically.

Q. Well , no"\v , if you are treating a patient medical1y, are you not simplyforestalling the day when he is going to end up being operated on if he has asevere hemorrhoidal condition?

A. Well , sir, the facts do not bear out what you stated. Many people withactive hemorrhoidal symptoms merely are having symptoms at that time be-cause of a specific reason , and once you can get them over this , they may notbe bothered again. You cannot predict that they wil (Tr. 1135 36).

Q. Doctor , did you prescribe Preparation H before this test?A. I have used it for some patients , yes.Q. To what extent?A. To no greater extent than I have prescribed other medications of a sim-

ilar nature.Q. Now , if Preparation H is as good as your conclusions would indicate

why would you not prescribe it for all of your patients?A. You asked me if I had done it in the past.Q. Yes?A. Well , I was not aware of the results of this study in the past. You mean

subsequent to this?

Q. Subsequent to this study.A. Well, the types of medications that a doctor uses , sir, are based on

many things. If it were necessary for me to prescribe an anal suppository oran anal ointment , I would probably use Preparation H , but I could not say

with certainty that this would be the only one I would ever use. For exampleI mig-ht find a patient who has taken Anusol before , and who has done wen



on Anusal. So I would not see any particular reason they need to change it inthis case (Tr 1213-14).

Dr. Lieberman , a proctologist who received his medical degreein 1928 , is the director of the Department of Proctology at theUnity Hospital , Brooklyn , New York , and a fellow and presidentelect of the International Aca,Jemy of Proctology (RX 77 A-Tr. 1219-1224). He sees about 300 patients in a year who haveactive symptoms of hemorrhoids (Tr. 1224). The therapy he em-ploys, he said

, "

wil depend upon the type of hemorrhoid andupon the degree of severity. The usual treatments would be eitherconservative treatment or injection therapy, or surgical removal

of the hemorrhoids" (Tr. 1225). He estimated that probablyabout one in ten or one in eight would fall into the latter cate-gory, and added

, "

This may be less than perhaps the estimatesthat might be given by other proctologists, because I have a tend-ency to shy away from surgery unless it is unavoidable" (Tr.1226). He further testified

, "

The injection treatment is especiallyuseful in internal hemorrhoids of an uncomplicated variety.

. .

(Tr. 1229). In October of 1963 , Dr. Lieberman undertook a doubleblind study to evaluate the action or lack of action of PreparationH suppositories and ointment. The medications used in the studyand the procedures employed in making the study werc the sameas those in the Dr. Berkowitz study which has been heretofore re-lated (Tr. 1045-1057; 1230-35). The patients selected for thestudy, 100 in number , were from Dr. Lieberman s practice , and afew were taken from the clinic at Unity Hospital. He chose thosewho had moderate to severe hemorrhoids as against the mildertypes (Tr. 1235). When asked how he determined what type ofmedication he would give to any particular patient, he stated (Tr.1240) :

I would first decide after examination whether I wanted to use a supposi-tory or ointment. And as I said , I have a leaning toward suppositories ratherthan ointments in the treatment of hemorrhoids , although I am far from de-nying that there is a place for each of these modalities. However, I woulddecide which one to use according to the findings. And. usually my feeling inthe matter is that if the pathology was externa1 or easi1y in reach of the pa-tient , very near the external opening, 1 would tend to use the ointment. If itwas internal , I would be more likely to use the suppositories . I also felt thatsuppositories had some additional benents in every case which also made melean more toward them.

He told the patients (Tr. 1243) :

. to use the ointment or suppositories in the morning, in the evening, and



following each bowel movement, or more often if he desired it in case of painor jf the symptoms were particularly severe on each particular date , but aminimum of twice to three times a day per patient.

I told him Ethe patientJ to continue with whatever treatment he was giv-ing himself at the time , questioning him of course on what treatment thiswas. And this \vouJd usually be limited to perhaps taking mineral oil , if hewas constipated , sitz baths in some cases , the patient might give it to himselfand watching his diet to avoid spicy foods , \vhieh sometimes patients dorof) their own accord. In other words , I told them to continue with any ofthese simple measures if he was already doing so , but didn t instruct him todo if he was not doing it.

The study was conducted over a period of 12 to 16 months (Tr.1251). The keys for the study (RX 8Z175 and RX 8Z176) werereceived by Dr. Lieberman in a seaJed envelope which he did notopen prior to the time the study was completed (Tr. 1234). Re-spondent' s Exhibits 8A through 8Z176 were identified in the re-ports made by Dr. Lieberman (Tr. 1045 , 1230). The foJlowing

eight tables are a compilation of the results appearing on themiddle of the first pages of the report forms of Dr. Lieberman forthe patients treated with Preparation H. The responses indicatedon the final examination of these patients during the study wereused. Identification of the cases in which Preparation H was usedis made by reference to the keys for the study (RX 8Z175 and RX8Z176). The report forms for the patients treated with Prepara-tion H used for these compilations and tables are: 8C , 8K , 8M , 80,8Q, 8S , 8Y , 8Z9 , 8Z11 , 8Z19 , 8Z31 , 8Z33 , 8Z35, 8Z41 , 8Z45 , 8Z47,8Z49 , 8Z55 , 8Z61 , 8Z63 , 8Z65 , 8Z67 , 8Z73 , 8Z75 , 8Z81 , 8Z85 , 8Z878Z93, 8Z95, 8Z97, 8Z99, 8Z101 , 8Z103, 8Z107, 8Z109, 8Z121,8Z123 , 8Z129 , 8Z131 , 8Z133 , 8Z139 , 8Z143 , 8Z145 , 8Z149 , 8Z157,8Z163 , 8Z169 , 8Z171. The report forms of two patients givenPreparation H, but who did not return for subsequent examina-

tion and observation , (8Z7 and 8Z51) were not included.

TABLE 1. NUMBER OF CASES IN WHICH RELIEF WAS AFFORDEDPercent. --- cent-

No. oJ No. of aae oj age

Vo. ca. ca.seB caseB casC!!caBes where where no where 1vhere nowhere iml'rove- impTollc- improve- im)JTove-

S!jmptom present. nJ.cnt mcnl ment ment

Pain 86. 13.Spasm 100%Bleeding 93. 30/(

Discharge 100%Protrusion 79. 20.Edema 96.Pruritus 100%(Itching)



TABLE 2. RELIEF OF PAIN: Grades of Response to TreatmentNumber PerCent

Grade of Response of CaseB of Total

- Excell ent complete remission 44.Good 34.FairNo Change 10.Failure 3.4%

Total

TABLE 3. RELIEF OF SPASM: Grades of Response to TreatmentNumber Per Cent

Grade of Respome of CaBeB of Tota!

A" - Excellen t-com p1ete remissionGood 66.Fair 33.No ChangeFailure

Total

TABLE 4. RELIEF OF BLEEDING: GTades of Response to TreatmentmbeT Per Cent

Grade oj Response of CaseB of Total

A" -Excellent-complete remission 43.Good 40.Fair

ChangeFailure

Total

TABLE 5. RELIEF OF DISCHARGE: Grades of Response to TreatmentNumberof Ca8e8

Per Centof TotalGrade of Respon8e

remission 25.37.37.

A" -Excellent-completeGoodFairNo ChangeFailure

Total

TABLE 6. RELIEF OF PROTRUSION: Gmdes of Response to TreatmentVllmber Per Cent

Grade of Response of Casea of Total

A " Excellent-complete remissionGood 37,Fair 33,No Change 20.Failure

Total



TABLE 7. RELIEF OF EDEMA: Grades of Response to Treatment

Total

19.53.23.

-- -

Numberof Case8

Per Centof TotalGrade of Respom;e

A " Excellent-complete remissionGoodFair

"D" No ChangeFailure

TABLE 8. RELIEF OF ITCHING (PRURITUS): Grades of Responseto T1'eatment

Numberof CaBea

Per Centof TotalGrade of ReBpona6

A " Excellent-completeGoodFairNo ChangeFailure

remission

Total

57. 1 'Ii28.14.

Based on the study and his general experience , Dr. Liebermangave the opinion that Preparation H " is effective in the treatmentof hemorrhoids , to varying degrees in various cases " (Tr. 1251) ;It would have an ameliorative effect upon pain in many cases to

varying degrees" (1252); and that " the hemorrhoids were re-duced in size . . in varying degrees in different cases" (Tr.

1252). He stated that it would improve the itching in a number ofcases to varying degrees, and "could render a patient asympto-matic of hemorrhoidal symptoms" (Tr. 1254). On cross-examina-tion , Dr. Lieberman testified in part:

Q. . . . When you dispensed the ointment or suppository to the patient , yougave it to him with some instructions. How did you know the patient followedout your instructions?

A. Several ways. First , the patient would tell me , the fact that I wou1dinquire of him what he had done , whether he had followed the instructionsand the patient .would inform me that he had.

Secondly, it is so rare for a patient to come-its practically unheard of fora patient to come and receive mec1ication from a doctor and then not use it.

Q. This is a matter of your opinion , is it not'A. Yes (TL 1271-72).

THE WITNESS: It is unheard of- I won t say it has never happened withpsychotics or bad neurotics that they wouldn t take the medication , but therewould be some reason for investigating his mental state if he continue tocome to the doctor and do€:;nt take his medicinr: because I am sure any of uscan assume that ,vhen a patient ('omp" l(1 . doctor , he is sincere in his desire



to get weJJ and looking for aid and he is definitely going to try the medica.tion.

It' s true he might stop after a while jf he doesn t have good effect but it'simply taken for granted , especial1y by a doctor, that the patient is takingthe medicine. \Ve don t go home with him and feed him the medicine. This isjust taken for granted (Tr. 1273).

Q. Wen , now , did you feel you were doing the most that you could for thepatients who came to you in pain and discomfort by offering them a supposi-

tory or an ointment

A. Definitely, yes.Q. \Vauld you treat your regular offce patients in the same fashion?A. In most cases, I would.Q. Simply give them a suppository or ointment and say that this wil re-

lieve the problem?A. Of course , because the ointment or suppository would very likely relieve

the pain that the patient had,

Q. You don t ever prescribe any adjunctive treatment to your patients?A. Yes , I do , in general , but in order to do a test , \ve have to ' have some

sort of basic ground rules and since the period of the test is a very short

time, two weeks , I could afford , and the patient could afford , to use the simpletreatment first, because in many eases, the simple treatment \vas enough togive him relief (Tr. 1276).

A. By what method I can cure hemorrhoids?Q. That's right.

A. First of aJI , the word "cure " as we ordinarily use it , as used in yourquestion , is a very hazy matter. In fact, in hospital records , even when weoperate upon a patient , we shy away from using the word "cure" because wefeel that would be more like a God-like prerogative to claim you have cured apatient and use the word absolutely in terms of a hundred per cent. We al-\vays mark that a patient has been improved , even jf we may personally feelthat he is cured. "\Ve say " improved. " That's for modesty and self-protectionmore or Jess.

Q. "\Vhen you do a hemorrhoidectomy and remove hemorrhoidal tissue froma patient , do you consider that he has been improved?

A. We mark it down on the chart that way. As I said , in many cases, Imay personaJJy feeJ that he has been cured but the word cured , but would youuse that word if, a fevi ' years later , he gets a recurrence? So we don t knowin advance, not being abJe to Jook into the future , whether he was reallycured in the absolute sense of the word. We always say "improved" eventhough we like to feel personaJly that we h8ve cured him,

Q. "That would your comment be if I told you the record in this case showstestimony from nine Board-certified proctologists who say that hemorrhoidsare cured by surgicaJ excision '

A. They are looking at the matter in a rather narrow form. I would dis-agree with them (Tr. 1286-87).


Initia1 Decision 70 F. T.

THE WITNESS: . . . On my examination , I could stil1 see that hemor-rhoids were pr2sent. v\le removed his symptoms in the case of a disease likehemorrhoids that is tantamount to a cure because almost everyone ' wi1 havehemorrhoids at some time in his life. Frequently, this is without knowing it.You and I , if we \vere examined, I think that a proctologist would probablyfind some hemorrhoids.

But you don t feel that we have hemorrhoids in the sense of hemorrhoidswith symptoms. When a man says he has hemorrhoids or piles , he usuallymeans symptoms of hemorrhoids because actualJy, most of us do have hemor-rhoids in a quiet state \vhich may give us no trouble , so this man was curedfrom his point of view. From my point of view , I could stil see hemorrhoids.But that was of no importance. It's not a sel'ious disease. It' s a minor condi-tion if it doesn t give you trouble and most of us live out our lives "withoutknowing "\ve had it.

The statistics are , I believe , that most of us win have hemorrhoids at sometime in life and probably 50 per cent of the population "\vill have hemorrhoidswith symptoms at some tinH' in his hfe , so this man would be cured , to al1

intents and purpose , that is cured with quotation marks around it , because ofthe possible double meaning' of the word.

A Proctologist would examine him and see piles. The patient could considerhimself as cured and to all intents and purposes , he is tantamount to cured(Tr. 1287-88).

The responde'1t called four medical witnesses who , in theCourse of their practice , treat a substantial number of hemorrhoi-dal cases. None of them perform surgery or give injection treat-ments.Dr. Frederick Steigmann , a physician who has been in the

practice of medicine since 1933 and specializes in internal medi-cine and gastroenterology, is a Diplomate of the Board of InternalMedicine ano Gastroenterology. He is the director of the Depart-ment of Therapeutics and Chief of the Gastrointestinal Section ofCook County Hospital-a hospital with approximately 3 000 beds

located in Chicago , Ilinois. He also serves as Associate ClinicalProfessor of Medicine at the University of Ilinois , College ofMedicine, and Professor of Gastroenterology of Cook CountyGraduate School of Medicine (RX 71A; Tr. 808-813). Dr. Steig-mann sees about 200 patients a year with active symptoms ofhemorrhoids (Tr. 814), of which number approximately 25% endup being operated on (Tr. 825). He testified that the kinds ofemollient substances he prescribes and uses for hemorrhoid casesare mostly Nupercarnal , Medicoe and Anusol ointment or suppo-sitories. He does not prescribe Preparation H

, 'j

Because as a rulewe do not prescribe so-called proprietary preparations which weare not familiar with" ; and he added

, "

I was not familiar (with

Preparation HJ except from what patients have been telling me



that they used the preparation , but I didn t know what it was(Tr. 831). He also stated

, "

They told me they have used the prep-aration , and they got good results at the time of their use" (Tr.823).

Dr. Fred J. Phillips , a physician who obtained his medical de-gree in 1943 , is engaged in the general practice of medicine , andhas an association of two other general practitioners, a surgeonand himself at Quakertown, Pa. During the past two years , he

has seen and treated approximately 100 patients with sympto-

matic hemorrhoids , and only one of such cases required surgery.In the treatment, he almost invariably uses a steroid ointment ora suppository that he made up from his own formula (Tr.835-843). He never prescribes Preparation H , explaining (Tr.852) :

There is a very simple reason. I never prescribe anything that can be sold

over the counter. As a physician , I think this is not good for me in my prac-tice.

I fecI that if a patient can buy something over the counter without a prescription , they are probably wasting money coming" to me in the first place.

He also added (Tr. 845) :

A number of the patients that have used Preparation H without jt beingprescribed by me , they have bought it themselves in the drug store , have toJdme they have been quite satisfied with the results that they have had .with it.I wouldn t propose to ehanr;c their way of taking care of themselves. Thesepeople have been found to have hemorrhoid perhaps on an examination forinsurance, an internal hemorrhoid which is entirely symptom-free to them,and they wil use an ointment or a suppository that they purchase over the

counter , with no ill effects whatsoever.

Dr. Russel1 John Sacco , who received his medical degree in1947, has been engaged in the general practice of medicine since1962 at Kinnelon, New Jersey. In the course of a year, he seesand treats about 250 people suffering from hemorrhoids , and inthe three year period he has not sent anyone of his patients onfor a hemorrhoidectomy or for injection treatment (Tr. 864-69).Dr. Sacco said that he does not give nor prescribe Preparation Hointment or suppositorics, but that he gives his patients samplesthat he has in his offce and "this seems to be adequate enoughto tide them over the (irJ acute phase" (Tr. 881).

Dr. Harold S. Feldman , prior to a medical degree which he ob-tained in 1949 , received a degree of Bachelor of Science in Phar-macy in 1939 , a l\laster of Science in Pharmacy in 1942 , and Doc-



tor of Philosophy in Medical Sciences with a Major in Pharma-cology in 1945. In addition to carrying on his general practice of

medicine in Livingston , New Jersey, where he has been for ap-proximately thirteen years , he is a Clinical Instructor in the NewYork Medical College and an instructor in Psychopharmacologyat Seton Hall Medical School (RX 72A-D; Tr. 887-891). Hetreats about 100 to 150 patients with symptomatic hemorrhoids ina year , and in the past thirteen years he has sent only one hemor-rhoid patient to surgery (Tr. 894). The testimony of Dr. Feldmandoes not reveal the names of the ointments or suppositories thathe employs in the treatment of his patients.

All of the four doctors just mentioned testified in substancethat, in the course of the treatment of patients suffering "fromhemorrhoids , they prescribe stool softeners, hot Sitz baths , andointments or suppositories; that the results they have achieved

with such treatment have been very good; and that , based ontheir experience, the use of ointments or suppositories in thetreatment of hemorrhoids in a vast maj ority of cases succeeds inreducing the swelling, relieves the pain , and stops the itching,where such symptoms are present due to hemorrhoids.

Dr. Arthur Grollman of Dallas , Texas , called as a witness bythe respondent, based upon his curriculum vitae , has had an im-preSRive career in the field of medicine and pharmacology. Com-plaint counsel , in his reply to respondent's proposed findings , re-

fers to Dr. Grollman as "an internationally recognized authorityon pharmacology" and "the author of a textbook on pharmacol.ogy ("Pharmacology and Therapeutics J which is used as astandard reference throughout the United States" (CRB , p. 13).Prior to the time he obtained his medical degree in 1930 , he re-ceived a degree of Doctor of Philosophy in Chemistry in 1923. Inthe course of his career , he has on many occasions appeared as anexpert witness on behalf of the Food and Drug Administration inproceedings of various types, and once for the Federal TradeCommission. At the present time , in addition to practicing medi-cine , principally as a consultant, Dr. Grol1man is a Professor andChairman of the Department of Experimental Medicine of theSouthwestern Medical School of the University of Texas (RX83A-L; Tr. 1750-54). Dr. Grollman in his testimony explainedhow a topical medication , which does not contain a local anes-thetic , might relieve the symptoms of pain , swelling, itching, andt-her symptoms which may be involved in a symptomatic hemor-

rhoid (Tr. 1763) :



Well , in the first place , it protects the surface. Any emmolient substancewil protect the surface and that in itself has a soothing effect , such as youapply petroleum , for example , on a superficial abrasion. It protects from theair and that has a symptomatically, at least , has an emmolient and soothingaction. The use of oils from time immemorial on the surface of the skin isbased on this action. In addition , of course , if they do penetrate and do exerta specific effect by overcoming the inflammation and the infection , this wouldobviously get at the root of the cause of the symptoms.

Dr. GroHman expressed the view that only a very smaH portionof the people--ne per cent or less-who were affected withsymptomatic hemorrhoids were subjected to surgery (Tr. 1791).On cross-examination , he said in part:

Q. Do you know of any drug or combination of drugs , Doctor , that wilcure varicosleJveins when applied to them?A. I know of no method , drug or otherwise , that might be said to be really

a cure for a varicose vein.

HEARING EXAMI ER ,JOHNSON: How about surgery'?A. I wou1dn t even call it that. That is a cure, in the sense of removing the

object , sucn as a had infection of the hand where you would cut off the hand.The same is true here. You are removing a tissue. You may remove the objectof the cause but I' d like to use the word cure in a pure sense , not used in thatsense, sir.

By Mr. :\IcMahon:Q. Well , would you elaborate on that a little bit , Doctor, as to just what

you mean by a cure?A. A cure , I use that word in the sense , for example , if you have an infec-

tion, pneumonia , and you take a certain drug and that pneumonia disappearsand there are no serious effects , that is a true, cure of the pneumonia. On theother hancI, if you have protuberant , let's say, as occurs in a prolapsed nemon-hoid and you cut it off , you are not curing it , you are just removing it andremoving the tissue .which happens to be obnoxious and undesirable in thepure sense , you are removing the symptom. You no longer have a mass butyou arc not curing- the condition. Your fundamental condition is stil there(Tr. 1777).

Seven consumer witnesses testified that self-treatment withPreparation H had achieved immediate and substantial improve-ment of their hemorrhoids (Vincent, Tr. 1809-1830; Garth, Tr.

1832-1844; Po1trek , Tr. 1847-1855; Clancey, Tr. 1856-1868; Val-entine, Tr. 1871-77; Rollins, Tr. 1884-1893; and Jones , Tr.1897-1910). They had found the drug of greater therapeutic benefit than other conservative measures- including prescriptiondrugs-to which they had resorted , and with its use had obtainedrelief from pain and itching and a reduction in the size of theirhemorrhoids (Tr. 1810-1814, 1817- , 1834- , 1840, 1842

1849-1850 , 1853 , 1859, 1861- , 1873- 187 1879-1881 , 1886

1596 FEDERAL TRADE COMMISSIO:- DECISIONS


1899-1901 , 1908-1909). Medical diagnosis had confirmed that sixof the seven consumer witnesses in fact had hemorrhoids. All ofthe consumer witnesses , with one exception (Rollins), testifiedthat they had been diagnosed by physicians and had been toldthat they did have hemorrhoids (Vincent, Tr. 1818-19; GarthTr. 1833-34; Poltrek , 1'r. 1849; Clancey, 1'1'. 1857-58; ValentineTr. 1877-78; and Jones , Tr. 1898-99).

John Garth , a taxicab driver , testified:

A. . . . Since I used that and it shrunk them up, mostly. I don t have notrouble with piles much no\\' as long as I use it but jf I don t use it , fromdriving a cab or bouncing around , it comes back on me again. As long as Iuse tho ointment about two or three times a \veek , I don t have too much trou-bJe (Tr. 1834).

Q. Has it been your experience and have you found Preparation H wouldrelieve any pain or discomfort you might have had from your hemorrhoids'!

A. It does.

Q. Have you found it aft-'ords relief from the itching?A. Very much SQ.

Q. Have you found it would shrink or reduce in size any hemorrhoids pro-truding from your anus

A. It do. If I use Preparation H 1ike I'm supposed to , it softens that upand it shrinks up and it goes back (Tr. 1835).

Mrs. Shirley Poltrek , a registered nurse , testified:

Q. Could you teJl us \vhat results , if any, you experienced from the use ofPreparation H?A. Yes , certainly. I fee1 that it was of tremendous relief , and being that

this \vas the one thing it was \vonderfu1.

Q. Did you find that it afforded you relief from any pain or discomfort youwere experiencing?A. Yes , the pain and the thrombosing subsided.

Q. Did you find that the use ofhemorrhoids in size?

A. Yes, it did (Tr. J849-1850).

Frank Clancey stated (Tr. 1861) .

Preparation H shrunk up or reduced your

Well , I used the suppositories on the advice of a druggist , where they sen, and the next day after-I had used them the night before-the itching

stopped altogether, and then the next day the soreness left. And within aweek it had shrunk right up. It was like a deflated innertube.

And Mrs. Denise Jones , a registered nurse , testified:

A. Well , I would say \vithin 24 hours , the itching would have stopped , and

AMERICAN HOME PRODUCTS CORP 1597


I would say "\vithin approximateJy t\vo or three days, the hemorrhoids wou1dJ,avc shrunk. I mean , they were no longer 8wo11('TI.

Q. You have testified you had some soreness or discomfort. What effect, ifany, did Preparation H haveJ on that?A. The soreness and discomfort was taken away \vhen the hemorrhoids

shrunk (Tr. 1899- 1900).

The respondent offered evidence pertainingogy of the ingredients of Preparation H:

to the pharmacol-

(a) BiodyneDr. George Sperti , the president and director of the Institutum

Divi Thomae at Cincinnati, Ohio , since it was founded in 1935 , is

one of only seven American members of the Pontifical Academyof Sciences , and has been responsibJe for a number of scientificdiscoveries in the fields of medicine and electricity. The Institu-turn is a graduate school of science , and its primary function isteaching and researching in the fundamental ' sciences, sllch asphysics , chemistry, biochemistry, and experimental medicine (RX73A-G; Tr. 930-34). In April 1941 , he obtained a United Statespatent "that covered a group or family of substances that we haddiscovered that stimulate the metabolism of ceJls-normal humancelJs , bacteria , ycast cells , many types of cells" which "we caJled. . . biodynes" (RX 73E-29; Tr. 936-37). The work was done atthe Institutum under his direction and control. Dr. Sperti testifiedin great detail as to the circumstances which led to the discoveryof 'JBiodyne" and the manner in which experiments were conducted. He tcstified that the laboratory experiments with micro-organisms and animal tissues demonstrated that "Riodyne" hadthe peculiar abi1ty to stimulate both the respiration and prolifer-ation of injured cens and thus to stimulate the healing processes

of nature (Tr. 930-949; Cook," (Tr. 1005-1012). Subsequently,this "Biodyne" was incorporated in a topical ointment on which apatent was obtained in August of 1943 , and was made availablefor the treatment of burns and wounds. The formulation of thatointment was the same in substance as that of the present Prepa-ration H Ointment (RX 73F - , Tl" 948-958; Shaul , Tr. 1016-1023) .

The Evans Research and Development Corporation of NewYork, :'ew York, at the instance of respondent, in November

Dr. E:ton S. CooK , Vice President and Dean of the Institution and Professor of Chemistry

and Biochemistry, holds a Ph.D. in onnnie chemistry from Yale Unjvers:ty and has eng3g-eoin extensive )'esearch on many phases of cellular metabolism and wound healing (RX 74A-H ;Tr. 998-1001),



1963 undertook an investigation to determine the chemical fac-tors in "Biodyne " and in May 1964 to evaluate the biological ac-tivity of "Biodyne." The results of such investigations were sub-mitted to the respondent in a report dated January 22 , 1965 (RX70A-I; Holland , Tr. 1689). Dr. Wiliam E. Holland, vice presi-

dent , and Mr. Ernest L. Klemm , a biochemist , with the Evans or-ganization , testified that the studies demonstrated that "Biodyne

(i) Is composed of such nutrients as amino acids , mineral saltsand the water soluble vitamins of the "B" complex , including rel-atively high concentrations of pantothenic acid (RX 70A, pp. 3

8, Tables I-IV; Klemm, Tr. 1714-15).(ii) Stimulates the growth and proliferation of mouse fibrob-

last cells in vitamin-deficient media , \vhereas without "Biodynesuch cells sicken and die (RX 70A, pp. 3 , 9-12; Holland , Tr.

1691; Klemm, Tr. 1714 , 1715- , 1725; RX 70B-I; Klemm, Tr.

1721-25) .(iii) Increases the metabolic rate of tissue cells and explants

from rat abdominal tissue. (RX 70A, pp. 3 , 12- , Tables VIVII; Holland, Tr. 1691-92; Klemm , Tr. 1714 , 1726-29).

The importance and justification of incorporating a substancewith these properties in a drug product for the treatment of hem-orrhoids was explained by the testimony of three physicians

whose medical testimony has heretofore bcen related , and whoare also qualified as pharmacologists. Dr. Gro11man pointed outthat fibroblast cells are always involved in the healing processand "act as a sort of mortar to heal the injured area" (Tr.1760). As a consequence , he was of the opinion that the laboratoryreports on "Biodyne " offered an explanation of the mechanism bywhich Preparation H :thicved the clinical results shown for it(Tr. 1765-66). Dr. Feldman testified (Tr. 901) :

Well , if this substance affords the necessary materials from which-whichwill aid in the tissue repair 01' wil act like a catalyst in the requirements of

the metabolic needs of the given injured cells , then these eens certainly wilbe stimulated to repair themselves-in other \Vords, this catalyst, this sub-stance , \vould encourage fibroblastic activity, which \vould then in turn repairthe celIs that have been injured.

Dr. Berkowitz , in relating the laboratory studies of "Biod)'neto the therapeutic effects of Preparation H , noted that "a hemor-rhoid exerts its effects. . . by creating an associated condition ofinflammation" (Tr. 1117); and that "Biodyne " nutrients can

provide "for the local inflamed tissue a source of nutrient mate-rials which are most important in the recovery and repairative

AMERICAN HOME PRODVCTS CORP. 1599


stages of the inflammatory processes present" (Tr. 1120). Havingreviewed the most recent laboratory studies of "Biodyne" (RX70A-I), Dr. Berkowitz testified that in his opinion they are ofconsiderable significance in explaining the therapeutic properties

of Preparation H (Tr. 1117) :

Now, I have been particularly impressed with the effects of the biodyne inthe tissue culture studies ",;here they showed , to my satisfaction , that when atissue culture containing fibroblast-and fibroblast are the major constituentsof fibrous tissue

, .

which is important in healing-and when biodyne was incor-porated in cultures where various thing's had been removed from these cul-tures , and where these fibroblast were not able to live , and when the biodynewas added , now the fibroblast became normal again , and regenerated , this to

me certainly gives rationale for the incorporation of such a thing in a prepa-ration where healing is important.

(b) Phen1l1me1' cu,.ic NitmtePhenylmercuric nitrate is a wel1-recognized antiseptic and ger-

micidal agent of long standing (Grol1man , Tr. 1761-62), and wasincluded in the formulation of Preparation H in order to inhibitinfection from bacteria (Sperti , Tr. 954-56). Such an agent playsan important role in the treatment of symptomatic hemorrhoidsin view of the complications stemming from infection and the im-portance of its elimination (Grol1man, Tr. 1756-1760; EpsteinTr. 1614-15; Hopping, Tr. 167; Marino, Tr. 237; Sarner , Tr.459-460; and Zimmerman , Tr. 576).

(c) Shark Liver OilThis ingredient of Preparation H is a source of vitamins A and, has local emol1ient and healing properties and tends " to have a

certain antiseptic action" (GroIlman , Tr. 1762; Hopping, Tr. 163;Marino, Tr. 210; ex 7 , 8; Sperti , Tr. 974-75).

(d) The Ingred1:ents Com.bined with the Respective Bases ofPrepamtion H Ointmeril and Supposit01'ies

Heretofore this initial decision sets forth the formulas of Prep-aration H ointment and suppositories, which describe the sub-stances included in the bases of such product in which "Biod-yne " phenylmercuric nitrate, and shark liver oil have beenincorporated. The advantages of any lubrication or emol1ient sub-stances in the treatment of hemorrhoids were recognized by mostof the medical witnesses (see, for example , GroIlman, Tr. 1763

1771-72; Berkowitz , Tr. 1119 , 1140; Marino , Tr. 207 , 212; Eisen-berg, Tr. 355 , 358), and Dr. Berkowitz outlined the effects of theentire product as foIlows (Tr. 1119-1120) :



The first thing that happens , I presume , is that by its local contact of theinflamed tissue with the ingredients themselves , it produces first ameliorationof pain. The "pain thereby lessens the degree of spasm that js present , and Ithink it is important to bring out that spasm , by causing actually a constric-tion of the muscle on the veins, actually increases the engorgement of theveins , because veins being different than arteries , fill from below up, andwhen you clamp down on something, you prevent blood in that vein from get-ting back , so that actually it becomes more engorged. So you set up a viciouscircle. When you reJieve the pain , you relieve the spasm , thereby some of thecongestion in the vein is decreased.

Secondly, I think the local applieation of the suppository 01' the ointmentby the nature of the specific constituents , provides for the local inflamed tis-sue a source of nutrient materials "\vhich are most important in the recoveryand the repairative stages of the inflammatory processes present.

Thirdly, I think it is not at all inconceivable. that some of the medication

some of the constituents in these local medications , are actual1y absorbed intothe general systemic circulation. It is an accepted fact thai the expense and

the accuracy of healing locaJly is also dependent on the generalized and sys-temic ability of the body to respond and the presence or absence of necessaryingredients systemically, not only locally. And certainly enough work hasbeen done ir. the last three or foul' years to shmv that many many substancescan bE absorbed sy"tcmical1y from the rectum.

I would say these are the three ways that I would presume the medicationmay physiologically work.

The respondent acquired the rights to "Biodyne" and "Prepara-tion II" and has marketed the ointment since 1952 for treatmentof hemorrhoids without changing in any material respect theformulation of the product as it was first marketed. The respon-dent has marketed "Preparation II Suppositories" since 1954 with-out any material change in their formulation (Sperti , Tr. 950 , 958962-63; Shaul, Tr. 1016- , 1023; Stipulation, Tr. 67-68; RX12) .

On rebuttal , complaint counsel presented two witnesses. Mr.William Weiss , a statistician for the National Institutes of Healthat Bethesda , Maryland , testified as to the validity of conclusionsdrawn by Dr. :\athan Jaspen , one of respondent' s witnesses (Tr.1948-2055). Dr. Jaspen, a professor of educational statistics atNew York Univel'sity, presented testimony relating to a statisti-cal analysis he made of the clinical reports of Dr. Lieberman andDr. Berkowitz (Tr. 1420-1438). The hearing examiner has not

recited the testimony of Dr. Jaspen in his initial decision for thereason that he does not consider it of any consequence in resolving any of the issues in this proceeding. Therefore , he wil notdiscuss the testimony of Mr. Weiss. Dr. Albert 1. JVendeloff, aphysician of Baltimore aryland , testified with respect to his



evaluation of the protocols and procedures employed in the clini-cal studies by the six doctors who were used as witnesses by therespondent (Tr. 2060-2088). It is the opinion of the hearing ex-aminer that the testimony of this witness was of no value , forwhich reason it wil not be related herein. Furthermore, com-plaint counsel have not cited or relied upon any of the testimonyof the two rebuttal witnesses in the proposed findings submitted

by them.

The hearing examiner has given consideration to the entire re-cord in this proceeding and in his opinion the facts can be summa-rized as follows :

Hemorrhoids are common among the adult population-partic-ularly in pregnant women and persons over the age of fifty-andestimates of its incidence range upwards from 50;X, The physicalbnormality which underlies the condition and technicalJy defines

its presence is the existence of one or more groups of dilated orvaricose veins in the hemorrhoidal venous plexus which may bedistended, together with the tissuc overlying them, at the distalportion of the rectum , the anaJ canal , or just exterior to the anus.In and of themselves , such hemorrhoidal varicosities are not trou-blesome and many-perhaps most-people have asymptomatichemorrhoids for years without being aware of the fact. Asympto-matic hemorrhoids are harmless and do not require treatment.Such a condition , however , may become symptomatjc from time totime as a result of onc 01' more exciting or complicating factorssuch as constipation , diarrhea , straining, trauma , infection, orconditions 01' activities which increase pressure on the hemorrhoi-dal veins. The most usual hemorrhoidal symptoms include one ormore of bleeding, pain , protrusion , swcl1ing, discharge , itching,and a sense of discomfort or ful1ness at the anus. These symptomsvary in degree from mild to severe , and symptomatic hemorrhoidsare frequently very painful , irritating and troublesome. The termhemorrhoids" is used to describe both the symptomatic and the

asymptomatic conditions. The mucosal , perivascular and skin- liketissue surrounding the varicose veins is integral1y involved in asymptomatic hemorrhoid condition. Symptoms are usual1y causedby complications-such as inflammation, edema , ulceration , orinfection-in the adjacent tissue rather than by the mere exist-ence of varicose veins. Such complications lead to spasm , swell-

ing, increased protrusion , pain , bleeding, discharge , itching, andsometimes thrombosis. If they are not treated , symptomatic hem-orrhoids may either become more serious and complicated or may



undergo spontaneous remissions over a period of time. In anyevent , hemorrhoids wil1 persist longer and be more troublesomelithout than with, treatment. Surgery to excise varicose veins in

the hemorrhoidal plexus (the operation is known as "hemorrhoi-dectomy ) is only indicated in cases of unusual persistence or se-verity, and is contra- indicated in the presence of heart, liver andkidney disease and certain other concomitant conditions. In prac-tice, physicians specializing in ano-rectal surgery ("Proctolo-gists ) perform such operations on a high percentage of their he-morroid patients. A substantial proportion of such patients arereferred to them by other physicians who have obtained negativeresults through conservative therapy. Physicians who do not spe-cialize in surgery, however , very rarely find it necessary or desir-able to recommend surgery for the treatment of hemorrhoids.Varicose veins in the hemorrhoidal plexus can only be removed oreliminated by surgery, and even then the recurrence rate is esti-mated at between ten and twenty percent. The vast majority ofhemorrhoid cases are successfully treated by conservative mea-sures. In most cases, conservative measures are suffciently effec-tive that surgery can be avoided. Topical ointments and supposi-tories are widely used and recommended for the conservativetreatment of hemorrhoids , and they are effective to varying de-

grees in the treatment of hemorrhoidal swellng, protrusion , painbJeeding, discomfort and itching.

It is the opinion and finding of the hearing examiner that thepreponderance of substantial , reliable , and probative evidence inthe record establishes that Preparation H ointment and supposi-tories have a significant therapeutic effect in the treatment ofhemorrhoids, and that , when used as directed , they wil1 , in mostcases , but not in all instances:

(1) Reduce or shrink hemorrhoids;

(2) Relieve pain due to hemorrhoids; and(3) Stop or relieve itching due to hemorrhoids; but that they

wil1not:(1) Avoid the need for surgery as a treatment for hemorrhoids

where surgery is indicated; or(2) Heal , cure , or remove hemorrhoids , or cause hemorrhoids

to cease to be a problem.The Federal Trade Commission investigated respondent' s ad-

vertising of Preparation H in 1954 and " on the basis of a scien-tific opinion" which it had obtained chal1enged a claim that the



product "stops bleeding." (RX 13-16; Rettig, Tr. 1923. ) Follow-ing communications and negotiations between representatives ofrespondent and the Commission (RX 16-18; Rettig, 'fr. 1923),respondent agreed to delete the challenged claim from its adver-tisements and submitted for the Commission s review proofs mak-ing that deletion and replacing it with the claim

, "

relieves pain(RX 17-18). In a letter dated October 19 , 1954, the Secretary ofthe Commission wrote to the respondent as follows (RX 19) :

Consideration has been given to the above matter involving al1eged viola-tion of Sections 5 and 12 of the Federal Trade Commission Act , in connection\vith the dissemination of advertising for Preparation H by Whitehall Phar-macal Company.

In view of the hdorm.ation presently 'in this file no further action is con-templated at this time. In arriving at this decision consideration has been

given to the modification of your advertising agreed to in your letter dated

September 16 , 1954, and illustmted by the revised copy submitted v...ith yourletter of September 21 , 1954. (Emphasis added.

The advertising claims now at issue in this case are the same asthose on which the Commission passed in 1954 (Rettig, Tr. 1917,1922; RX 21; CX 9-14). The formulation of the product is thesame now as it was in 1954 (Shaul , Tr. 1016- , 1023). It is theposition of the respondent that "After the Commission closed itsfile in 1954 , respondent proceeded in the belief that its advertis-ing had received Commission approval" and under the related cir-cumstances "every consideration of equity militates against theissuance of an order to cease and desist" (RPF , p. 59). There isno merit to the contention. Respondent's witness acknowledgedthat with the words

, "

no further action is contemplated at this

time " the Commission had left the door open to further consider-ation of the matter (Rettig, Tr. 1933). In P. Lo,'illard Co. v. Fed-eml Tmde Commission. 186 F. 2d 52, 55 (4th Cir. 1950), the

Court said:

It must not be forgotten that the Commission is not a private party, but abody charRed with the protectioJ'. of the public interest; and it is unthinkablethat the public interest should be allowed to suffer as a result of inadvertenceor mistake on the part of the Commission or its counsel where this can beavoided.

In Wallace Corpomtion v. National Labor

al. 141 F. 2d 87 , 91 (4th Cir. 1944), it is said:Relations Boa,.d, et

Settlements approved by tIle Board should ordinarily be observed and ad-ministrative orders should not be lightly disregarded. . . but these are guidesfor the exercise of discretion by the Board , not limitations upon its power.



CONCLUSIOI\S OF LAW

1. "Preparation H Ointment" and "Preparation H Supposito-ries" are "drugs" within the meaning of Section 15 (c) of the Fed-eral Trade Commission Act 05 U.sC. 55 (c)).

2. The Federal Trade Commission has jurisdiction of the sub-ject matter of this proceeding and of the respondent.

3. The advertisements referred to in Paragraph Five of the

complaint herein were and are misleading in material respectsand constituted , and now constitute

, "

false advertisements" asthat term is defined in the Federal Trade Commission Act.

. The dissemination by the respondent of the false advertise-ments , as aforesaid , constituted , and navv constitutes , unfair anddeceptive acts and practices in commerce , in violation of Sections5 and 12 of the Federal Trade Commission Act.

ORDER

It is oTdeTed That respondent American Home Products Corpo-ration , a corporation , and its offcers and respondent's representa-tives , agents , and employees , direct1y or through any corporate orother device , in connection with the offering for sale , sale or dis-tribution of Preparation H Ointment or Suppositories, or anyother preparation or preparations of substantially similar compo-

sition or possessing substantially similar properties , do forthwithcease and desist from directly or indirectly:

1. Disseminating or causing the dissemination of any ad-

vertisement by means of the cnited States mails or by any

means in commerce, as " commerce" is defined in the FederalTrade Commission Act , \yhich represents directly 01' b v im-

plication that the use of Preparation H Ointment or Supposi-tories, or both, wil :

(1) Reduce or shrink hemorrhoids in aJl cases;(2) Avoid the need for surgery as a neatment for

hemorrhoids where surgery is indicated;(3) Stop or relieve itching duo to or ascribed to hem

orrhoids in all cases;(4) Relieve pain attributed to or caused by hemar-

roids in all cases; or(5) Heal , cure or remove hemorrhoids 01' cause hem-

orrhoids to cease to be a problem.

2. Disseminating or causing to be disseminated by any

means for the purpose of inducing or which is likely to in-


1524 Opinion

duce, directly or indirectly, the purchase in commerce, ascommerce" is defined in the Federal Trade Commission Act

of said preparation or preparations , any advertisement whichcontains any of the representations prohibited in Paragraph1 hereof: PTOvided, howeve,' That nothing contained in thisOrder shall prevent nor be construed to prevent respondent

its offcers , representatives , agents or employees from repre-senting, or from disseminating or causing to be disseminatedby any of the means or for any of the purposes referred to inParagraphs 1 and 2 hereof any advertisements which repre-sent, that the use of Preparation H Ointment and Supposito-ries , or either of them , or any other preparation or prepara-tions of substantially similar composition and intended usewi1 in most cases:

(a) Be of significant therapeutic effect in the treatment ofhemorrhoids;

(b) Enable persons with hemorrhoids to avoid surgery ex-cept in unusually severe or persistent cases;

(c) Reduce or shrink hemorrhoids;

(d) Relieve pain due to hemorrhoids; or(e) Stop or relieve itching due to hemorrhoids.

OPINION OF THE COMMISSIONDECEMBER H , J 966

By JONES Commissioner:This matter is before the Commission on an appeal by com.

plaint counsel from the initial decision of the hearing examiner inwhich he sustained some of the a11egations in the complaint, re-jected others , and issued an order substantia11y different from theproposed order attached to the complaint. Respondent, urgingthat the hearing examiner s decision and order should be upheldhas not appealed.

The complaint, issued on August 28 , 1964 , charged that respon-dent made false representations in advertising its suppositoriesand ointment , sold under the trade name of "Preparation H" forthe treatment of hemorrhoids or piles ' in violation of Sections

5 and 12 of the Federal Trade Commission Act.Among the statements made by respondent in its advertising of

1 The words "hemorrhoids" and "piles" RTe synonymous and wil be used interchangeablyherein.


Opinion 70 F.

Preparation H suppositories and ointmentsplaint was based were the foJlowing: '

on which the com-

Preparation H * * * actually shrinks hemorrhoids without surgery. ..

* * *

Preparation II relieves pain promptly-heals injured tissue. The secret? OnlyPreparation H has the new wanrler substance that we call Bio-Dyne to drawthe body s 0 \\11 healing oxygen the painful area.

Clinical tests show Preparation H shrinks hemorrhoids without surgery.Relieves pain-stops itching. Shrinks piles.

For the first time science has found a new healing substance \-vith the as-tounding ability to shrink hemorrhoids, stop burning rectal itch and relievepain-without surgery or painful injections. * * " In fact results were sothorough that sufferers werE' able to make such astounding statements asPiles have ceased to be a problem!" " " * Heals injured tissue back

to normal,

The complaint aJleged in Paragraph Six that through the use

of these advertisements, and others, respondent has represented

that the use of its products " wi1:

1. Reduce or shrink piles;2. Avoid the need for surgery as a treatment for piles;3. Eliminate all itch due to or ascribed to piles;4. Relieve all pain attributed to or caused by piles;

G, Heal , cure or remove piles, and cause piles to cease to be a problem,

In Paragraph Seven of thepreparations will not in fact:

complaint it was al1eged that the

1. Reduce or shrink piles;2. Avoid the need for surgery as a treatment for piles;3, Eliminate all itch due to 01' ascribed to piles;4. Re1ieve all pain attribl1ted to or caused by piles;5. Heal , cure or remove piles or eliminate the problem of piles;6. Afford any relief or have any therapeutic effect upon the conditions

known as piles or upon any of the symptoms or manifestations thereof in ex-cess of affording temporary j'elief of minor pain or minor it(',hing associated\vith piles,

The hearing examiner found that respondent's advertising did

make the claims alleged in the complaint with respect to the useof Preparation H to avoid surgery and to heal, cure or removehemorrhoids , which he found to be false , and to reduce or shrinkhemorrhoids , which he found to be true in most cases. He agreedwith respondent however, that respondent's advertisements did

not make the representations alleged in the complaint that Prepa-Respondent' s advenisenwnts are set forth, in greater detail in Finding 6 of our Findings

of Fact.

'The terms " products,

' "

prepal'a '-ions " and "PrqJaration H

to Preparation II ointments s.nd suppositories.as user1 herein , each refeJ


1524 Opinion

ration H would relieve "a1l" itch and pain and found that respon-dent' s representations that Preparation H would re1ieve itch andpain meant only that it would relieve some itch and pain and thatthese representations were true in most instances. Fina1ly, heconcluded that Preparation H would have a "significant therapeu-tic effect in the treatment of hemorrhoids" (I. D. , p. 1602).

Neither counsel has appealed the examiner s findings and con-

clusions that respondent falsely claimed that Preparation H wi1avoid the need for surgery as a treatment for hemorrhoids and

wi1 heal, cure or remove hemorrhoids. The hearing examinerfindings and conclusions with respect to this aspect of the case

are accepted and adopted.Complaint counsel' s appeal chaJIcnges the examiner s findings

as to the meaning of the claims which respondent's advertising

makes with respect to relief of itch and pain and also his conclu-sions that "in most cases" Preparation H vdll shrink piles, stopitch and relieve pain and that it has a significant therapeutic ef-fect in the treatment of hemorrhoids. These are the only substan-tive issues , therefore , which are before us on this appeal. Com-plaint counsel has also raised questions about the scope of theorder proposed by the examiner which must be determined on

this appeal.

THE EV!1ENCERESPECTING THE CA USE AND TREATMENT OFHEMORRHOIDS

Hemorrhoids ' are masses of dilated weak-wa1led veins locatedunderneath the mucous membrane of the lowcl' portions of therectum and under the skin of the anal canal and the perianal area(F. 1).' Hemorrhoidal veins do not have valves , and hence tendto dilate if the coJumn of blood flowing into these veins causes ex-cess pressure. Other factors leading to the development of hemor-rhoids include an hereditary tendency to develojJ hemorrhoidsabnorma1ly long periods of standing, straining, diffculty with

4 There are two types of hemorrhoids: internal hemonhoirls. which occur above the )H'ctinateii,,, ann are coverl'd by mucosa: and extern,,1 hemorrhoids , which Oee\-'I' belo\\ the pectinateEne and are covered hy skin (F. 16). Respondent RI'l'UeS that hemonhoids must be definedto include the surrounding mucosa and skin as \\ell as the v",jns themselves. \VhiJe \\e haveconcluded that the definition set forth above is in acconl with the weight of evidence of reconlinclu(ling- the testimuny of four of respondent s own medical expel'ts (Tr. 817 , 83R, 867, 8 ), as

well as the examiner , who defined hemorrhoids as "var;cose (dilated) veins in and around therectal upening" (l. , p. J.14.0). oU,. conclusLons with respect to the issues in this cas!' wouldnot be affected by the use of the definition Pl'oposed by I'esponder. t. See ('.fl. , PP. 160g- 1611

infrn.5 Citations refcr to the Finding-s of Fact entered by the Gomrr. ission herein.


Opinion 70 F. T.

bowel movement, impacted stool , pregnancy and cirrhosis of theliver (F. 19).

The most common symptom of internal hemorrhoids is bleed-ing. The other principal symptom of internal hemorrhoids is pro-lapse. ' Secondary symptoms include discharge and itching whichmay bc caused by such discharge. Itching, however , is not a usualsymptom of internal hemorrhoids. Pain rarely occurs in inter-nal hcmorrhoids since the sympathctic ncrvous system which ser-vices thc region above the pectinate line where internal hemor-rhoids are located do not contain sensory nerve fibers (F. 20,23) .

The most common symptoms of external hemorrhoids, on theother hand , arc pain and swelling. Pain in external hemorrhoidsis frequentl ' caused by thrombosis or blood clot known as an ex-ternal thrombotic hemorrhoid. Other causes of pain in externalhemorrhoids are inflammation , swelling, ulceration and infec-tion. Swelling may result from thrombosis or from edema. Itch-ing may occur in external hemorrhoids but normally only as theresult of the healing of the hemorrhoid (F. 20, 22 , 23).

Surgical removal is the only means by which either internal orexternal hemorrhoids can be permanentJy cured. Any measuresshort of surgery merely provide palliation and do not effect acure. However , even surgery does not effect a complete cure inevery case (F. 26) .

While hemorrhoids themselves cannot bc eliminated withoutsurgery, hemorrhoidal symptoms may frequently disappear, atleast temporarily, on their own account within several nays totwo weeks (F. 25). :Vloreover , hemorrhoidal symptoms can insome instances be alleviated by various types of therapy (F. 27

28). A common treatment for the symptoms of simple , uncompli.cated internal hemorrhoids of small size is injectional therapy,which causes scar tissue to form and cut off the blood vessel feed-ing the hemorrhoid. A more rccent treatment used for the symp-

toms of internal hemorrhoids is thc baron ligation method wherebya ligature of rubber is placed around the internal hemorrhoid'18 another means of cutting off the blood circulation to thehemorrhoid (F. 27).

Finally, a so-called "conservative" course of treatment may beG " ProlaJ!se" r",fers to an jnt ,.nal h"morrhoid which has fallen outside the anaJ canal and

nrotrudes to the surface (F. 18).7 PlIin , ho\\evi'r , may oc.c.ur i" inf1"'fluenl clises of severe eompJicated int.erna1 hemorrhoids

as il rcsult of snasrn or strang-J ation cau ed hy pro1ajJse or as the )' uJt of an involvementof tissucs beyond the pedinate line (F. 20).


1524 Opinion

utilized to relieve temporary minor symptoms associated withboth internal and external hemorrhoids. These methods includecleanliness, altering the diet to eliminate irritative foodstuffscOntrol of the bowels to ensure a smooth, soft stool , warm bathswitch-hazel , boric acid , local anesthetic , ointments , suppositories,avoidance of standing, and manual re-insertion of prolapse. Oint-ments and suppositories contain lubricants which may protect theanal and rectal canal against the passage of hard , dry stool. Suchlubricants may also serve to relieve dryness and soften the skinas well as provide a psychological advantage; many people derivemental relief from the fact that some sort of treatment is applied(F. 28).

DISCUSSION OF ISSUES RAISED ON APPEAL

A. Meanin.Q of Respondent's Advertisements Resl'ectil1.Q Reliefof Itch and Pain

The hearing examiner found that respondent's representationsthat its products would "relieve pain" and "stop itch" meant onlythat some itch and some pain would be relieved or stopped. Heheld that the complaint allegations that respondent claimed that

all itch" and "al1 pain" would be relieved were not proved (I.pp. 1538- 1539) .

Respondent during the hearing ca1led seven consumer wit-nesses to support its position that its advertisements did not claimthat Preparation H would relieve all itch and pain. ' These wit-nesses testified that to them respondent' s advertising meant thatits products would "relieve" hemorrhoids (Tr. 1815), "give meimmediate relief and stop the itching and pain" (Tr. 1837), bring

relief from pain and itching" (Tr. 1851), "bring relief to me(Tr. 1863), "get me over a bad time " (Tr. 1875), "give ( J re-

lief" (Tr. 1887) and "give me some relief" (Tr. 1902). The examiner noted this consumer testimony in his discussion

of the meaning whieh should be attributed to respondent' s adver.tising. However, he did not expressly rest on it in reaching hisconclusion that respondent' s advertising did not represent that allpain and itching would be stopped or reljeved by its products.Rather, he \vas apparently chiefly influenced in his conclusion bythe fact that" (tJ he word 'a1l' is never used in any of the adver.

8 The seven consumers consisted of an B tl"onautic:'l technici8n , a tf1"Xicab operator pOTtera city conncilman and three regisleretl nurses.


Opinion 70 F.

t;sement to describe the relief to be afforded by the product fromitch and pain" (I. , p. 1538).

We do not agree with the examiner that the omission of theword "all" conclusively establishes that the advertisement inquestion did not represent that Preparation H would relieve allpain and itch. It is c1ear that in determining the meaning of rep-resentations made by respondent the Commission must concern it-self not only with the express language of the assertion in ques-

tion but also with the overall impression which it conveys. TheCommission may "draw upon its experience in order to det.ermine* * * the natural and probable result of the use of advertising

expressions (E. F. Drew Co. Inc. v. 235 F. 2d 735 , 741(2nd Cir. 1956)). See also to the same effect Stauffer LabomtoT-ies Inc. v. Federal Trade Commission 343 F. 2d 75 , 78 (9th Cir1965). :l10reover , the Commission is not bound in making such de-termination by the statements of witnesses that they were not de-

ceived. As the Tenth Circuit recently reiterated:

If the Commission can find deception without evidence that the public ,vas

deceived * * * it can make the same finding on the basis of its visual exami-nation of exhibits , even though numerous members of the public have testifiedthat they were not deceived.

(Double Eagle Lubricants , Inc. v. 360 F. 2d 268 , 270 (10thCir. 1965), cert. denied 384 U.S. 434 (1966)).

Respondent' s repeated references to the "healing" powers of itsmedication punctuate its c1aims with respect to pain and itchingand in our view are equivalent to a dec1aration that the relief af-forded by Preparation H wiI be total. If a consumer is led to be-1ieve that his hemorrhoids wiI be cured by using Preparation Hhe wiI necessarily also understand that all symptoms associatedwith these hemorrhoids will also disappear. Moreover, evenstanding alone we are of the view that the implication of respon-dent' s representations that its products wiI " stop" itching andrelieve" pain is that they wiI stop all itch and pain even though

they do not use the word "alL" Indeed , the testimony of the con-sumers called by respondent on this point would seem to bear thisout and certainly does not support respondent's interpretation of

these claims. K ot one of these witnesses stated explicitly that he

interpreted the advertisement in question as representing that

only "some " itch and pain v.;uld be relieved by using respondent'products. These witnesses testified fairly flatly that respondent'advertisements meant that Preparation H would stop pain anditch.


1524 Opinion

We therefore conclude that the examiner was in error in his in-terpretation of these representations and we specifically find thatrespondent' s advertisements represented that its products wi1eliminate all itch due to or ascribed to piles or hemorrhoids andwi1 relieve all pain attributed to or caused by piles or hemor-rhoids.

Truth Respectingor Falsity of Respondent's RepresentationsEffcacy of Preparation H

The four issues to be considered herein in determining whetherrespondent' s representations are misleading in a material respectare: (1) the abilty of respondent's products to "reduce or shrinkhemorrhoids ; (2) the effect of respondent's products on pain;(3) their effect on itching; and (4) the existence of other thera-peutic effects of Preparation II products.

(1) The Ability of Preparation H to Reduce or Shrink Piles

The examiner found that Preparation H would reduce orshrink hemorrhoids "in most cases , but not in al1 instances " but

eannot remove or eliminate the varicose veins themselves. Eachof complaint counsel's medical experts testified that PreparationH cannot shrink or reduce the size of hemorrhoids , which theydefined to mean the hemorrhoidal veins themselves (Tr. 128-129,212-213 276 369-370 436-437 500 563-564 629-630 740). Twoof respondent's witnesses specifically concurred (Tr. 1497,1668)." Respondent did not dispute the accuracy of this testimonybut contended that under its definition of hemorrhoids as encom-passing both the hemorrhoidal veins and the surrounding tissue, itsproducts wi1 reduce the swelling in the tissues surrounding thehemorrhoid and hence that its claims that hemorrhoids will beshrunk or reduced in size by its products are correct.

Respondent' s advertisements state flatly that "Preparation II9 O hel' experts testifying for respondent stnted generally that Prepa.ration H would reduce

the she of hemorrhoids (Tr. 1112-111:\ , 1252 , 1;,30). However , It dol's not appear from theil"testimony ",heth",!" they were referring to the shl'nkaC'c of the vejn themselves or to thereduction of swelling in the hemonhoidal tissues. Two of reSl)ondent' s othe,- witnesses e"plicitlytestified that the reduction which would OCCl'r would be in the edema or swelling (Tl' . 81570). Four of rcspondcnt' r.n umcr witnesses testified that in their c"perience Prepetrr, tionH had "shrunk up '" their hemolThoidR (Tr. 1S!'8- 50, 1834 , 1861 , 1899- lfJOO). -We do notbeJieve that their testimony, assuming th,' piltient can deteJ' mine for himself whethel' or notthe hemorrhoid ha shrunk, outweighs the clear implication which we find re pondent'adveJ, cment5 had in this regard that use of PrejJaration H WQuld shrink ail hemorrhoidsand \\ould heal them.

10 This is apparent y al o the rationa!c of the examiner s conclusion that " in most cases

Preparation H wi1 rcduee or shrink hemorrhoid , aJ:hough he did not articulate the ba is for

his conclusions (l. p. 1602).


Opinion 70 F.

shrinks hemorrhoids (e. CX 13). In no case do they make anydistinction between shrinking hemorrhoidal veins and hemorrhoi-dal tissue. Therefore , the clear implication is that the shrinkagewhich wil take place win not be limited to the covering tissuebut wil include the underlying- hemorrhoidal vein. Indeed , in thecontext of respondent's total advertising message, respondent'claim with respect to shrinking hemorrhoids is tantamount to anassertion that the hemorrhoidal condition, including an of itssymptoms , wil be eliminated and even that the hemorrhoids wilbe cured or healed. Yet respondent has conceded on this appealthat its products win neither cure nor heal hemorrhoids.

Since , as respondent concedes and the examiner found , Prepa-ration H win not reduce the varicosity of hemorrhoidal veins orcure hemorrhoids , the reduction , if any, which win occur wil notbe of the type implicitly promised by respondent' s advertising.Thus , even if we were to assume that some reduction of swe1Jngin the surrounding tissue does take place, which claim is notwhony supported by the evidence " respondent's absolute claims

with regarc1 to shrinkag-e can only be regarded as highly mislead-ing.

For an of these reasons we conclude that the hearing examinerwas in error in his finding that respondent' s Preparation H is cor-rect;" represented as shrinking hemorrhoids and we hold thatrespondent' s representations that its product would reduce orshrink piles are in al1 respects false and misleading.

(2) Effect of Preparation H on PainThe hearing examiner concluded that respondent' s Preparation

H win relieve pain in most cases. Respondent accepts this finding,as wen as the provision of the order proposed by the examiner tocover representations respecting pain. Complaint counsel argues

that the finding is in error and that the order is unduly limited.Complaint counsel' s medical witnesses 12 testified either that

Prejlaration H win have no effect on pain or that it win afIordonly temporary reJief of minor pain associated with hemorrhoids(Tr. 131 , 207 , 279 , 372-373 , 439-440 , 503 , 562 , 632-633 , 744). TheH Sowe of he 1.esJ")ondeJlr \vitnesses took t !' position that the jHoduct may have an effect,

on swp1li:) Dr. "" Dun,, stated tha: i: W;lS " of valw.," as a l.lbl' icant in reducir. g s\\ e;ling (Tr.14(1) , Dr. Epstein sai,! :hat it " can reduce edem" 01' swe1ling " (Tr. 15(0) D1"- haacsofltes:if. erl t\)at it "cr, n rerbce the sccoYHial'Y s'.cllin . sCl,onda1"Y elcema HnG innHmrr. ation '" (Tr.

1GGSI. 01: the othl'l' h"n,; , cOI'lvlaint counsel's witness D . f'OjJC testificd that it wO' I,d have

no effect, nOIle wh;ctsoever ' on :his symptom (Tr. (;8. " To the S!iwe ef:'ed see also thete,;ti'T, or. Y of Dr. S"l'nCl" at Tr. 4G3 ar, (1 Dr. JIO)'ll!n" at Tr. )2(1

A brief "escription of the qualiC,cations of eaen of tncse experts is set fortn in Finding 8

of Ollr Fim1ing-s of Faet eTltere(1 herdr..


1524 Opinion

consensus of these experts was that pain is a symptom associatedalmost entirely with external hemorrhoids and that even withthis type of hemorrhoid if the pain is caused by thrombosis , a

principal cause of pain in such hemorrhoids , it cannot be affectedby the application of any external treatment such as ointment andsuppositories. Where pain in external hemorrhoids results fromulceration , inflammation or swelling, some of these witnesses tes-tified that pain might be relieved to a minor degree by the lubri-cants contained in Preparation H, although other of complaint

counsel' s witnesses were of the opinion that Preparation H wouldnot even alleviate pain when attributable to these causes (Tr. 129648, 742-743). Finally, it appears from the testimony of com-plaint counsel's witnesses that in the unusual case of internalhemorrhoids where pain results from spasm 01' strangulationPreparation H wil rarely be of benefit. (See Tr. 631-632.

Respondent did not attempt to refute the testimony of com-

plaint counsel's witnesses concerning the causes of pain in hemor-rhoids or to offer any scientific explanation as to how their prod-uct in fact affected these causes of pain. Instead , respondent basedits argument that pain would be relieved by use of its products onthe testimony and clinical studies of its medical experts " that

persons using Preparation H or other ointments and suppositoriesgained relief from pain and on the testimony of consumer wit-nesses to the same eft eet.

In general , respondent's medical witnesses did not seriouslycontrovert much of the testimony of complaint counsel's medicalwitnesses respecting the effect of Preparation H or of supposito-ries and ointments in general to relieve pain.

Four of respondent's eleven medical experts testified not withrespect to Preparation H , which they did not use in their practice,but with respect to general conservative courses of treatment, in-cluding various ointments and suppositories which they pre-scribed for their patients. The first of these witnesses, Dr. Steig-

man " testified that ointments and suppositories wil relieve paindue to hemorrhoids " in some cases" (Tr. 822). Dr. Philips" wasof the opinion that certain ingredients in the ointments and sup-

10 A brief description of respondent's merl.kal experts is contained in Finding: \J of our

Findings of Fact entered herein.'Dr. Steig-mall, a speciaJjst in internal medicine , testified on the basis of his use in his

practice of ointments and suppositories as part of a oI\se1"yatiye C01Jl'se of treatment (Tr. BOgctseq.

Dr. PhiJips , a !!eneral practitioner, tes1.fad on the basis of his use in his practice of an

ointment and suppository which he prescribed as part of a general conservative course of trea1-ment (Tr. 8 843).


Opinion 70 F.

positories which he prescribed relieved pain (Tr. 854-855); butnone of these ingredients are found in Preparation H. Dr. Saccoplaced primary emphasis in his testimony on sitz baths ratherthan ointments and suppositories in relieving the symptoms ofpain (Tr. 873). Dr. Sacco also stated that nature wi1 clear up the

symptoms of external hemorrhoids in about two weeks and theacute symptoms of internal hemorrhoids within a period of one toten days (Tr. 875). Dr. Feldman " testified general1y that his

conservative course of treatment can render the patient free of

the symptoms of hemorrhoids" (Tr. 896), but did not express anopinion concerning the value of Preparation H or any other oint-ment or suppository when not used as part of a general course oftreatment.

Of the six medical experts cal1ed by respondent who testifiedwith respect to clinical studies which they had conducted , fourhad prescribed Preparation H as part of a general conservative

course of treatment, including sitz baths , stool softeners, and

other like measures (Tr. 1107, 1275 , 1571-1572, 1675), and ac-cordingly could not testify on the basis of their actual experience

as to what effect use of Preparation H by itself had on the relief ofpain. Nevertheless, even when prescribed as part of an overal1conservative course of trcatment , neither the testimony nor theclinical studies conducted by these doctors supports respondent'claim that use of Preparation H by itself would permanently elimi-r.ate al1 pain.

Dr. Epstein , testified that in "mild to moderate" hemorrhoidsPreparation H, when used as part of a conservative course

trcatment

, "

win relieve pain where pain is a symptom of hemor-rhoids" (Tr. 1569-1570), but he did not specify whether the re-lief was partial or complete. He also acknowledged that symp-toms of hemorrhoids subside spontaneously and hence it can

never be determined in a given instance whether the remission ofa hemorrhoidal symptom was spontaneous or due to treatment(Tr. 1613). When asked whether Preparation I- would have thesame beneficial effects without the conservative adjunctives in his

'" Dl'. Sacco

, "

l'ecia1ist in intcrnnJ medicine. testified on the basis of his experience in his"enend 1,rl1ctice with conservative IT('3S\ll'CS l1lescl'ibed for the treatment of hemorrhoills (Tr.864 etsGq."Dr. Fddmi'll , a geneJ'ni lHactitioncl' and j)sychophtlfmaco o"ist , testif,ed on the basis of

his use in his lwaPticc of ointments (1n(1 SU1")Poito 'ie as pal't of a conservative cOUl'se ofHtment (Tl". 887 , ct ,"cq.

Dr. Epstein , a gastl'ente!"ologisl, testified on the o!!sis of a study which he and Dr.lsancson. a surgeon, w01'kin ,: indejJel dentiy of each other , conducted at the re(J\lest of respon-dent cov rin!: 119 Jliltients This study in 1!11- 10r;2 is d scribec1 in F. 12 of OUI' Fil1ding-s ofFact entered herein.


1524 Opinion

program he could only speculate that this was a "fair assump-tion" to make (Tr. 1572). Dr. Isaacson '" who reported that 30%of the patients in his study of Preparation H required surgery,stated , in response to the question as to whether Preparation Hwi1 relieve pain due to hemorrhoids: " It can" (Tr. 1667). Onfurther inquiry as to whether he had "any idea" how PreparationH acted to relieve the secondary symptoms of hemorrhoids, hefrankly admitted, "1\0 sir , I do not" (Tr. 1680). Dr. Berkowitzconcluded that '''',

,', ,',

treatment with Preparation H was effectivein reducing pain in the vast majority of patients who had pain(Tr. 1173), and was "sure" that the other conservative measureswhich he prescribed had an effect on the results which he obtained(Tr. 1107). Dr. Berkowitz s study showed that 28:7" of thepatients sti1 had some symptoms of pain at the end of the study.This should be compared with Dr. Lieberman s study in which25;r, of his patients were referred for surgery and 55:70 withpain still had this symptom at the end of the study. Thus, themost that Dr. Lieberman " could claim for the product in reliefof pain was that it "would have an ameliorative effect upon painin many cases to varying degrees" (Tr. 1252).

Dr. Young, " who conducted the only clinical study in which ad-junctive conservative measures were not prescribed along withPreparation H , testified that on the basis of this study he felt thatPreparation H was "of value" in the relief of pain and that( w J ithin a matter of a short time , and I mean by that within 12

to 24 hours, patients say that they received some benefits andwithin a week, most of the patients say that pain has disap-peared" (Tr. 1497-1498). This conclusion contrasts strikinglywith respondent's claim in its advertising that pain will be re-lieved "promptly * * * in minutes" (CX 13). Furthermore , Dr.Young conceded that nature "definitely takes a large hand" incorrecting some of the minor disorders associated with hemor-rhoids (Tr. 1487) and thus that his studies were "subject to someerror because some hemorrhoids not treated at all wi1 clear

" (Tr. 1471). It should be noted that the results of Dr. Youngstudy bear litte relationship to his experience in his practice in

----

'"Note 18, Bllp'"

'" Dr. Be!'lww;tz , a specialist in intcl'nal mellicine anll Dr. Lichcnnan , a proctologist. workingimlejJE'ndently of each othe)' , each made a stuny at respor,dent' s request in 1963- 196 of 1\16

patients. This study is described in Finc1i:ng- 13 of our Findinr,s of Fact entered herein"Note 20, SUjlra.22 Dr. Young, a surg-€on , testified on the basis of a study which he and Dr. Burt had con-

ducted at the request of respondent in UL'iS- 5D covering 127 patients. This study is described

in Finding 11 of our Finding of Fuet entered herein.

1616 FEDERAL TRADE COM:IISS!ON DECISIONS

Opinion 70 F. T.

which , according to his testimony, most of his patients "go to sur-gery" (Tr. 1481) and those who do not , undergo a general con-servative course of treatment which keeps them only "fairly com-fortable" and Ivhich "must be continuous. They can never getaway from it * * *" (Tr. 1501). Dr. Burt '" who assisted Dr.Young in his study, after testifying on direct examination thathis patients reported that they were relicved of pain with Prepa-ration H (Tr. 1531), clarified this response on cross-examinationby stating that " it won t relieve all of the pain" (Tr. 1541) andthen concluded virtually in the language of the complaint, thatPreparation H wiI "give temporary relief from minor symp-toms" (Tr. 1542), thus indicating that if any pain is relieved , it is

minor. Final1y, Dr. Grollman testified that an emollientmight" relieve pain due to hemorrhoids (Tr. 1763).At best the testimony of respondent's medical experts " would

support the conclusion that Preparation H may afford some relieffor pain in some instances when used as part of a general con-

servative course of treatment. Yet nowhere does respondent in itsadvertising indicate that its product should be used in connectionwith other conservative measures , such as diet , sitz baths or thelike.

Moreover , the evidence is clear that pain is normaJJy associatedonly with external hemorrhoids and is not a symptom common toall hemorrhoids. Yet the overal1 purport of respondent's adver-tisements is to imply that pain is a usual symptom of all types ofhemorrhoids. Thus , many hemorrhoid sufferers may be misled byrespondent' s advertisements and take its Preparation H as a pre-cautionary measure even though they do not have an.v pain and inmost circumstances may never experience pain.

n Note 22 supra.'Dr . Gro1lman , a l1harmacologist , testified on the basis of his g neral kno\\Jeup:e uf the

condition of hemorrhoids.

" The con umer witf'e 5eS aJ1pearinl' for resj10nclent testified that the liEe of PrejJar;,tioll

had relieved lJain , discomfort or 'Ooreness resultin from hemorrhoid . Ho\vever, it i im!Jos ihleto determine whether the reduction in pllin ,, hieh they c18im had beer. achieved came as theresult of the prodl1ct l1sed or nH'rely by the passage of time. Therefore. we j,('Jieve that themedical testimony on this issue is enH:led to greater ""lCil:ht in our rietcrJl. ination. Dr. Eerko-wiL:'s tl'stimony indicatio!; that the only paio- reli"vio;; r l1ality of Preparation JI was as anemu:iient OJ' lubricant (T!' 11:,0) WU111c\ mean that it would have no effect on pain symptomscaused by thromhosis , spasm or straog-btioo which fire major c;Juses of pain :'1 h"rro,'r('oids

20), HesjJor.dent's own pharmaco;ogical evidcrJce respecting the in Tedients of Prepara-tion H would Seem to support th, testimony. PrC(Jal'ation H ,ioes not have any special Piiin-relieving ingredients. Respondent itself advertises thH.t its pl'ducts do not contain any alleo"thet:cs (eX 5C) and its active ingredient, B:o-Dyne , whieh is o much stl'es ed !l8 having

healing " Qualities, does not contain any speei"l pH.;n !-i!Jer O! pain reJievcr . The only )Jain-reJieving ingredicnts in )' reparation JI would seem to be the l\lbricant which it contains.(See F. 28.


1524 Opinion

We therefore conclude that respondent's representation thatPreparation H will relieve all pain is false and misleading.

The hearing examiner in his findings and conclusions not onlycame to the opposite conclusion but also found affrmatively thatrespondent' s product will " in most cases" relieve pain. We do notbelieve that this finding is supported by the evidence which wehave discussed above. Accordingly, we reject this finding and holdthat at best respondent' s products may afford some temporary re-lief against some types of pain associated with certain types ofhemorrhoids.

(3) Effect of Preparation H on ItchingThe hearing examiner found that respondent only advertised

its products as stopping some itch and that since he also found

that Preparation H wi1 stop or relieve some itching due to hem-orrhoids in most cases, he concluded that its advertising claims

were true. As we pointed out above, we have concluded that res-pondent' s claims were unqualified and represented that respon-dent' s products "would stop itch " meaning all itch under a11 con-ditions. The evidence on the effect of respondent's products onitch must be evaluated in terms of this unqualified claim whichwe find is contained in respondent' s advertisements.

According to complaint counsel' s witnesses , itching is only inrare cases a symptom of hemorrhoids and is almost always causedby some other condition such as fungus infection or by unknownfactors (F. 23)." The testimony of some of these witnesses indi-cated that whether or not itching in the anal and rectal area isconnected with a hemorrhoidal condition , it would not be pal-liated by Preparation H. Dr. Manheim pointed out that" (tJ hereis nothing in this formula that could possibly be considered

as * ,', ,', (aJn anti- itch agent" (Tr. 278). Dr. Smith was of theopinion that Preparation H " doesn t relieve the itch * * " (sinceJ

there is nothing in this prescription itself which would reduceitching or relieve itching" (Tr.741). Dr. Pope stated thathe "would not agree that even with * * * minor irritationthat it gives any particular relief, and it certainly doesnin the symptoms that are more severe *, '. ,p' (Tr. 633).

-.--

6 This testimony would se€m to be LorTIC out "by the clinical studies offered into evidenc:e byr€sIJOmlcnt. Thus, Dr. Epstein s stuuy indicDtes that only 7 of the 33 patients who participated

had it(,hing uue to hemorrhoids (RX '-'G. 6N , 6-0, GQ, 6U , 6V , 6X).

In Dr. Isaacson s study only 25 of ehe R5 patients particiPRting in the study reported having

symj)toms of itching due to hr,morrhoids.Dr. Lieberman, it, his study, reJJorted only 7 cases of itching due to hemorrhoids among the

48 patients who IJarticipated in the study and used Pr",p!il'ation H (I. , p. 1590).


Opinion 70 P.

Respondent' s own pharmacological evidence respecting the ingre-dients of Preparation H would seem to support this testimony.N one of the ingredients contained in respondent's products wasclaimed to have any anti-itch properties (Answer , par. 3). Indeedrespondent specifical1y advertises its products as not containingany anesthetics (CX 5C).Other of complaint counsel's medical experts felt , however

that Preparation H may provide some temporary relief for minoritching due or attributed to hemorrhoids (Tr. 131 , 215 , 372-373,439-440, 503-505 , 566). The only explanation given by any ofthese doctors for its effect on minor itching was that it acts as lubricant and may thereby possibly relieve dryness and soothesurface irritation. (See Dr. Sarner s testimony at Tr. 440).

As in the case of the proof relating to pain , respondent did notattempt to refute any of complaint counsel's witnesses concerning

. the causes of itching or offer any scientific explanation as to howits product would affect the causes of itching. Again , its case insupport of the truth of its claims that Preparation H will relieveitching was based primarily on evidence of clinical studies and onthe testimony of its medical and consumer witnesses. Howeveronce again the testimony of respondent's medical witnesses gener-ally failed to support the totality of respondent's flat assertionthat its preparation would stop itching and at best only warrantsthe finding that Preparation H may in certain cases temporarilyrelieve some of the itching due or ascribed to hemonhoids. Thusthe only conclusion that Dr. Young, for example , whose clinicalstudies revealed that itching stopped for 27 out of 28 of his pa-

tients involved in his clinical study (Tr. 1501-1502), could drawfrom the results of his study with respect to itching was that itindicate.d that Preparation H had " some bearing" on this symp-tom (Tr. 1472). Dr. Steigman concluded that the use of ointmentsand suppositories will stop itch " in some cases" (Tr. 822). Dr.Isaacson s clinical study revealed that 10 out of his 25 patientshaving itching symptoms derived no improvement as a result of

eparation H (F. 12). Dr. Phillips testified that a local appiica-tion would only alleviate itching if it contained a steroid , antihis-tamine or anesthetic (Tr. 855-856), none of which may be foundin Preparation H. Dr. Lieberman s study indicated that out of the

7 cases of itching whieh he had found among his 48 patients stud-ied , 4 were totally relieved of this symptom at the conclusion ofhis study (I.D. , p. 1090). He was able to conclude from these re-sults only that Preparation H "wi1 improve itching in a number


1524 Opinion

of cases to varying degrees" (Tr. 1252). Only Dr. Burt , among anof respondent's medical experts , stated flatly that Preparation

, based on his observations , relieved all itch (Tr. 1542). In thelight of the weight of all of the other medical testimony offeredby both complaint counsel and respondent, in our judgment theconclusion is compelled that in fact Preparation H wiJ not , whenused by itself , relieve all itch in all cases of hemorrhoid suffering,and we so find. Finally, as we noted with respect to pain , respon-dent' s witnesses, with the exception of Drs. Young and Burtprescrjbed other conservative measures which could easily haveinfluenced the results obtained in their medical practices and clin-ical studies (Tr. 819 , 842-843 , 870-871 , 895 , 1107 , 1275, 1571-1572, 1675); and as three of respondents witnesses testifiedthe symptoms often subside spontaneously within a short periodso that results apparently attributable to Preparation H mayactually be due to the passage of time (Tr. 875 1471 1487 1613).

Four of respondent' s seven consumer witnesses stated that theyhad had itching associated with their hemorrhoids and that thisitching had been relieved by Preparation H (Tr. 1835, 18591873-1874, 1899-1900). However, this testimony is of dubiousprobative value in view of the fact that the cause of these wit-

nesses ' itching was not disclosed. For example , some itch iscaused by the process of healing of the tissues (F. 23). If this wasthe case with these witnesses , there would be no way of determin-ing whether their itch had been stopped by Preparation H or bythe healing of their hemorrhoidal tissues.

Respondent' s representation that Preparation H will stop itchdue to hemorrhoids is unqualified. It neither disclosed that muchof the itch in the anal and rectal areas is not due to hemorrhoidsnor did it state that itching is not a symptom of the great bulk ofthe hemorrhoids which people usually suffer from. When viewedin the context of the totality of respondent's advertising, the im-plication is clear that itching is a common symptom of all hemor-rhoids and that such itching wiJ stop by using respondent's prod-ucts. The record does not support this claim.

Accordingly, we hold that the hearing examiner eITed in hisfindings and conclusions on this claim and conclude that the evi-dence fully supports the allegation in the complaint that Prepara-tion H wiJ not eliminate all itch attributed to or caused by hem-orrhoids and wiJ at best only afford temporary relief of minoritching associated with hemorrhoids.

The hearing examiner not only sustained the truth of respond-

1620 FEDERAL TRADE COMMISSIOC\ DECISIONS

Opinion 70 F.

ent's claims with respect to itch but affrmatively found that

when used as directed respondent's products wil "in most casesbut not in al1 instances" stop itching. We do not find any recordsupport for this finding and accordingly we reject it.

Complaint counsel's witnesses testified that in their opinion

Preparation H may provide some temporary relief for minor itch-ing due to hemorrhoids (""pm). We do not read the testimony ofrespondent' s witnesses as making substantial1y any differentclaim. We certainly do not read this testimony as supporting theexaminer s finding that itching wil be stopped in most cases. Astatement such as Dr. Young s that Preparation H "has somebearing" on itch certainly does not support this finding; nor does

Dr. Lieberman s testimony that itching wil be improved "in anumber of cases to varying degrees." Dr. Steigman specifical1y

confined his observations that Preparation H wouJd relieve itch-ing to "some cases. " Final1y, Dr. Philips testified that withoutcertain ingredients (which Preparation H lacked) an ointment orsuppository wil not benefit itching. Accordingly, we hold that theexaminer s finding on this point was in error and that the mostthat the evidence indicates on this point is that respondent's prod-ucts may afford temporary relief against itching in some cases.

(4) Therapeutic Effects of Preparation HThe hearing examiner concluded that Preparation H ointments

and suppositories "have a significant therapeutic effect in thetreatment of hemorrhoids, and that, when used as directed , theywiJl in most cases, but not in all instances" shrink hemorrhoids,relieve pain and stop itching.

Counsel for the parties herein have assumed that the exam-

iner s finding on this point was based on his prior findings andconclusions with respect to the effect of respondent' s products on

pain , itching and swel1ing or protrusion. These were the only spe-cific symptoms enumerated by the examiner as affected by Prepa-ration H and respondent in its brief confined its discussion of theevidence to these three symptoms.

27 In stating the issues raiserl on ll!Jpea1 in its brief, respondent pointed out that the examinerconcluder! that respondent s product has ' a significant therapeutic. effect in the treatment of'

this condition " '" . ::01'e specifically, he found'" .. .. that Preparation H will: (1) reduceor shrink hemorrhoids: (2) relieve pain due to hemorrhoids; and (3) stop or relieve itching

auI' to hemorrhoids " (Resp. Brief, p. 5).In the argument portion of its brief respondent summarized the evidence supporting this

findinr; of the examiner as follows: "All six doct()rs were ()f the ()pini()n that PreparatiDn Hhas a sip:nit1cant therapeutic e!Tect in the treatment ()f hemDr/hDids, Th.,y testified, on thestrength ()f ()bservatiDn made in the CDurse of clinical studies and in the Jight Df their extensivetraining. education and experience , that Preparation H would reduce the size of hemorrhoids,


1524 Opinion

We do not agree with the examiner s conclusion that Prepara-tion H when used as directed would have a sign ficant therapeuticeffect in the treatment of hemorrhoids.

The dictionary definition of therapeutic when used as an adjec-tive is "of or pertaining to the healing art , concerned with rem-edies for diseases , curative. " When used as a noun , it is defined

simply as "a healing or curative medicine, " 28 Thus, the exam-iner s finding of significant therapeutic effect if used by respond-ent in its advertising would convey an impresion which is en-tirely at variance with the conclusion of the examiner that Prepa-ration H wil not heal or cure hemorrhoids-a conclusion whichrespondent does not even chal1enge on this appeal. For this rea-

son alone, the examiner s conclusion would seem to be erroneous.Even if we should view the examiner s finding as relating

solely to the effcacy of respondent's products to relieve hemor-rhoidal symptoms as distinct from the hemorrhoids themselves

we do not believe that the claim has probative record support."It is significant that the only hemorrhoidal symptoms which

respondent itself claimed would be affected by Preparation Hwere itching, pain and swelling.

As we have already pointed out, the evidence does not supportthe examiner s conclusion respecting the effcacy of Preparation Hon respondent's specific claims respecting itch , pain and shrink-ing. We , therefore , do not agree that the examiner s further con-

clusion of significant therapeutic effect has any greater support inthe record.

re:ieve pain and itching- and avoid the need for SUTg-ery exccpt in unusually severe or persist€nt

cases " ((Rcsp. Brief, p. 30; see complaint counsel's brief generally, pp. 2-6; 52-54.).'s Webster s New International Dictio1!l1ry. 2d Ed. , unabridged.'I' \Ve note that most of the medical witnesses cal1ed by both coum;!'1 agr d that hemorrhoids

coulri be both symptomatic and asymptomatic and that if any symptoms were relieved , howevertemporarily, to the h molThoid sufferer, this .was equivalent to relief of hiH hemorrhoidH (Tr.141-143, 181-182 , 23a, 23,,), 341-342 , 352 , 457 R14 818 , 884-885. 1080-1081. I13G , 1a75 , 1377.1552 , 1668 , 1754 , 17,'57- 1758). However, we do not read any of this testimony as implying onthe part of the witness any opinion that the use of Preparation H had any significant thera-peutic effect beYONl the particular symptoms referred to in respondent's advertisements andseparately rliscussed above.

ao There is little douht that the absence of any other claimH was deliberate. For exampleespondent made no claim in its advertisin;; that its product is effective for bleeding and has

not done () in its advertising ince 195,j when it agreerl with the Commission to delete the

claim that PrelJfuation H "stops bleeding " (Tr. U123, RX 17-18). In fact, in its labeling itspe"jlicaJly ciH,tions tbe consumer to consult a physician in case of hleeding. Yet the examinerI1nrlin ,: on therapeutic effect could possibly be construed , if respondent made the c!a:m in ihadvertising, which it might well do so , 8S representing that Preparation H would affect bleeding, among "n.. of its significant thereapeutic effect , Whe!'eIlS the evidence established thlltno such efTeet will occur (Tr. 682- 683, 315-316 , 424).

n The c1jnical studie.' conducted by Dr.. Epstein , Isaacson , Berkowitz and Lieberman , offeredinto evidence by respondent. dcaJt with the effect of the use of Preparation H or similarointments on prolapse , bleeding and spasm and discharge (RX 6, RX 7 , RX 8), indicating that


Opinion 70 F.

We conclude that the examiner s finding with respect to thetherapeutic effect of Preparation II is merely a summarization ofthe purport of his findings on itching, pain and swelling and mustbe rejected to the same extent that these findings were rejected.

THE ORDER

In view of our rejection of some of the examiner s findings andconclusions as discussed above, we are entering OU1' own order inthis matter consistent with our findings and conclusions respect-

ing the properties of respondent's products and the false and mis-leading nature of respondent's representations concerning the ef-ficacy of its products.

In determining what order is necessary to ensure that respon-dent' s misrepresentations respecting the effcacy of its drug prep-aration will not occur again, it is of primary importance toconsider the segment of the public which is most likely to beparticularly affected by these misrepresentations.

Our mandate under the la\v was graphically expressed byJudge Clark when he emphasized that " the law is not 'made forthe protection of experts , but for the public-that vast multitudewhich includes the ignorant , the unthinking and the credulous.' Charles of the Ritz Distributing Corpomtiol1 v. Fecleml TmdeCommission 143 F. 2d 676, 679 (2nd Cir. 1944).The need for protection of the public becomes particularly

acute where misrepresentations are made with respect to healthaft",l" lIse of this product these symptoms h:1(1 djsapPcf!red UJ' improved. 1'he1' e are certainflJndament,,! weaknes es in €;lch of these stuo1ies: (a) in each, the pnticnts wcre instl'ucted touse other con,ervativc measures alonR \\i h J' rt'jJflration H , thus makin " it impossible todetel' mine \\hether the results achieved were attdbuttlble to PreJ1ar.'tion H 01" the olhe"mcasu,' es: (b) thc Epste:n- Isaacson studies did nut use any control , thus failing to eJiminRtcthe psycholncdcal elTect derive,J from the use of a placcbo: the Berkowitz and Lieberman studydid use a contl'ol- th" )Hesc:rivtion dnw " Anusol"' but thcn \\;JS aplJ1nently no sig;nificantdilTc!' cnce behveen th.. rt'sults ont.'ined fl Qm sair) control and Prej1annion H Clnd no evidencewas introduced concerf1in", tnc valt:e of "Af1\Jsol"; (r) the symjJtoms of hemonhoids have atendency to n' mit within 8. pe,.iod of horn sc\' ej' al days to t\\o weeks which coincides with thetime period.' cOVel'e() by the clinic,,: studies, Furciwl'!1ore , in the ca.'e of bleeding a sho"l'ng madeby responc1l'1Jt cannot b, I'e a!'h'd as J1roh Ltive of any si."-nificant thera)wutic effect in vie\\ ofrespondent s a,,;reement 50111e 12 yea!'s 8.'-0 not to mal,e the claim that its product ",jJ slopbIeE'dinL\, It is .'i niticant that l'es110ndent neve!' fwked it.' o\\n medicaJ experts about theiropinion to the thenljwutic efTeets of Pn'p;lratior, H on th"se specific syml1tom nor diel anyof its medical e"perts testify thnt these symptoms would be affected , (with the sole l')Ccej1tion of

Dr. Burt, who testified that " sjn l1le mild hleedin " would be re:ieved (Tr. 1,) O) ), Beyond theirtestimony on th" Sj)ecific symptDIl', of itching, )l:'.in lInd shrir.king, respondent s other witnc.'.'psconfined th",ir ol'ir,ion.' resppctin . the L.;eneral eJT,ci1cy of Prepal'ation H to such observations asI'rejJaration H " is an cHicncio\ls agcnt in the conservative management of 11atients with mild tomoderi1t hemon huidnl (:is('a ' and can render Cl jJatient with symj)tomatic hemonhoidssymptom frce" (Dr. Epstein , Tr, 1,:;(;0: err, j,hasi.' ulded), or " that treatment with Prepa\"ation

could definitely render the vrimnrily initially SY!nptom!'tic het!JOI"l"hoid to a statu.' wl1el'e it\\as no Jong-eJ' a p1'obiem " (Dr. Berkowitz, TI' 111:-;; emphasis added),


1524 Opinion

claims and the effcacy of drugs since the appeal of such represen-tations fal1s most poignantly on those persons who are in distressfrequently the aged and the infirm. Moreover , to clay, with Medi-care a reality, many people may be consulting doctors for the firsttime in their lives. They wil1 be learning that aches and pains anddiscomforts of al1 kinds may be symptoms of diseases which theyhad never heard of before or never before associated with theirown distress. Consequently, advertised claims of drug effcacy wil1have increasing relevance to this segment of our population andwi1 offer hope of relief to mi1ions in our population who mayhave previously ignored such anvertising not realizing their pos-sible application to their own conditions. Accordingly, it becomesof even greater importance today to make sure that representa-tions respecting health claims and relief of distress are absolutelyaccurate and do not contain promises , impressions , or even highlyveiled suggestions of effcacy which are in any sense false or mis-

leading. It is with these basic principles in mind that we mustfashion the type of prohibitive provisions which are necessary tobe included in the order in this case.

A. Product Application of the OrderThe order entered by us applies to representations made by re-

spondent with respect to both Preparation H and to any medica-tion sold by respondent in the future for the treatment of hemor-rhoids. Certain of its prohibitions apply additionally to any drugssold by respondent.

The order proposed by complaint counsel provided that it wasto be applicable to Preparation H "or any other preparation orpreparations of substantia.lly sl:milar composition or possessingsubstantially simila,' J)opeTties (emphasis added). In our judg-ment, making the application of the order turn on a determina-tion of whether or not a future preparation of respondentcontains " substantially similar ingredients " or possesses " substan-tially similar properties" would be extremely diffcult of enforce-ment and would only be productive of controversy and probablylitigation.

The Commission is empowered to enter an order of suffcientbreadth to ensure that respondent will not engage in violations ofthe law in the future. .Jacob S,:ega. v. 327 U. S. 608 , 611

(1946) ; C. v. RubeToid Co. 343 L'. S. 470 , 473 (1952). More-over , in the field of drug advertising we have special responsibil-ity to avoid ambiguity in our orders so that their prohibitions

1624 FEDERAL TRADE COMMISSIOl\ DECISIONS

Opinion 70 F.

against misleading cJaims with respect to the effcacy of a medica-tion are clear and easily understood and wil in fact ensure thatsuch claims wil1 not be repeated in the future. Furthermore , theCommission must make sure that the effect of its orders cannot beevaded or avoided by a simple change in the ingredients of theproducts to which the order applies. Erickson Hai,' Scalp Spe-cialists v. 272 F. 2d 318 , 322 (7th Cil" 1959), cert. denied362 U.S. 940 (1960).

In the instant case respondent made five specific claims aboutthe therapeutic effects of its products, each one of which wasfound to have been false. The pharmacological evidence with res-pect to respondent's products indicates that it has three basic

ingredients: a " live yeast cel1 derivative " shark liver oil and phen-ylmercuric nitrate , a bacteriostatic agent having certain germ-ar-resting properties (Tr. 463-464), plus various lubricating agents.It is apparent that it would not be too diffcult for respondent toreplace these ingredients with others and put on the market an.other hemorrhoidal preparation whieh might havc no differenteffect on hemorrhoids than its present Preparation H and yet bewhol1y outside the order if the order applied only to Preparation

H or to other preparations containing similar ingredients. Ac-cordingly, in our judgment it is essential that the order enteredagainst respondent be suffciently broad to cover any hemorrhoi-dal preparations sold by respondent regardless of whether theiringredients are the same or different from those contained in

Preparation H.

If respondent should in the future develop a truly effcaciousremedy for hemorrhoids, which would enable it to representtruthful1y properties of its product which it could not now repre-sent under this order, it can petition the Commission for anamendment of the order to permit such truthful representationswith respect to such product." (See Section 3.28 (b) (2) of the

Commission s Rules of Practice. ) Thus , respondent is not re-stricted under this order from developing new hemorrhoidal rem.edies. The only limitation which this order places upon respondentis the obligation to petition the Commission for an amendment ofthis order if in fact respondent succeeds in developing a hemor-

'" \Vc al' !' "wan" that under the pl'ovision of Section :-\55 of the Fede!'al Food , Drug- &Cosmetic Act jf respondent develops a "new drug" within the meaning of that section , itwould be reQuired prior to introducing it in commerce to obtain the approval of the Secretary

of Hcalth , Education and \Velfare for all effcacy claims made for such drug in its labeling. OUforder accordingly makes provision for th:s situation by JJ1' ovifiing that the Com;nission will takesuch approval into account in respondent' s applicaiion for modification of the ""ithin order.


1524 Opinion

rhoidal preparation which heals or cures hemorrhoids or has anyone or more of the jloperties which respondent is prohibitedtmder this order from representing. We are of the view that anyburden which is thereby placed on respondent in having to seekan amendment of this order before placing such new product onthe market is far outweighed by the importance of protecting theJlub1ic in advance against possible misrepresentations involvingpublic health and safety. The gravity and widespread nature of:respondent' s misrepresentation with respect to Preparation H re-quire no less.

Finally, we believe that it is essential not only to prohibit spe-

cific representations with respect to hemorrhoidal preparationssold by respondent , but also to cover misrepresentations as to theeffcacy of any other drug product marketed by respondent. Re-spondent is hardlv a stran"er to Commission proceedings. In 1989respondent' s wholly owned subsidiary, Wyeth Chemical Co. , wasthe subject of a Commission order Droscyibing future use ofclaims which it had made falsely representing the effcacy of thedrug "Freezone " to remove corns (Wyeth Chemical Co. Dkt.3754 , 29 F. C. 281). Only two years ago respondent was prohi-bited by order from continuing to misrepresent that their "Out-gro " would restore ingrown toenails to normal (America?1 HomeP,' oducts C01"pomtiol1 Dkt. 847S (1963) (63 F. C. 933J. " In

both of these cases , as in the case before us , the gravamen of thevioJations which respondent and its subsidiary were found tohave engaged in was the making of misleading exaggerations andmisstatements in advertisments with respect to the effcacy ofthe drugs which each was selling.

The law is clear that an order issued by the Commission need

" In adrlition to the two litig'ateo proceedings referred to ahove, respondent and itsllbsidi,ni(' helve bcen named in no le s thf\l1 i"X other Commission complaints, each of whichalso chn\'l'ed miSlejJre entations a to the effca1'Y of jlfOpJ' ietary dru".s. Of these, two weredismi sed on t:lP L':l"und that the subsidiary involv€\i had been (1issolved (Whitehall Phal"ll(("ul,Inc. alle dnl' IT.isrEprEsentations as to the effcacy of thE (1nw "A81wrt8ine, " an anal"esic lDkt4718 ,! F. C, 1009 (HHi) J and /hwcin Co" char ing misrcpresentations flS to the efTcClcy of

Anacin " another ana!,esic lDkt. 5'213, 4 C. 1130 (l j8) ). one \\as dismissed on th

;\'

rollnd that the respondents therein hml filed a peti;ion asserlinr; discontinuance anr1 agreeing:that if the sarne clairr.s \\eJ'e again made, " then they ag,' Ee that the facts in thi case 8r

alleged in the com)llaint (Whiteha.ll rhal'Hneal Co. , et al. charg:inr; misrejJr "tations as to

the ef!icacy of " lI;J's Culd T"biets, " a cold rcmedy lDkt. 5038 , 4-1 F. . 1197 (ID,j8)l); OIlewas dismissed On a stijJu:ation of discor. tinu,\nce (Whitehall Pharmocal Co. chargingmis!' cpresentatiO!l5 CIS :0 the df. y of the drug " KJ'ijJtin," another cold rerr_€dy lDkt. S75 , -17

. 1450 (j!)50) J) , one terminated ir. n cons"nt order (Amcrican Home Products CU)"j'.

char ,-dng" misl'clJresentations as to tbc effcacy of the drugs " lnfraRuh" and " Heet " tworemedies sold fa\' the tJ' eatment of the )18in of arthritis and other diso,.d€rs (Dkt. 6755

, ,

;-1

C, 1464 (1958) l) : ar, d one, a?:ain chRl"g;ing misrcpresentations with respect tv the drugAnacin," was di missed due to the iapse of time sir,ce the issuance of the comp:8.i:lt (AmericanHome I'rod1tc! Corp :U;d. (1965)J f67 F, C. 4301)


Opinion 70 F. T.

not be confined to the particular product or even type of products

sold by a respondent, particularly where the respondent has , bypast conduct, demonstrated that the misrepresentations withwhich it has been charged are not isolated examples of its prac-tices. Thus , in Carter Products v. 323 F. 2d 523 , 532 (5thCir. 1963), the allegations in the complaint were limited to spe.cific misrepresentation of the product "Rise " a shaving cream;but the order issued by the Commission prohibiting respondentsfrom making such representations extended to "any other mer-chandise" sold by respondent in commerce which included a de-odorant

, "

Arrid " and a drug, " Little Liver Pi1s. In affrming

the order the court noted that the Commission had twice " liti-gated orders dealing with similar offenses" with respect to other

products sold by Carter. In Niresk IndustTies , Inc. v. F.T. , 278F. 2d 337 , 343 (7th Cir. 1960), cert. denied 364 1J. S. 883 (1960),the court also affrmed with approval an order of the Commissioncovering all products sold by respondent , which consisted of aline of kitchenware, although respondent's misrepresentations

constituting the subject-matter of the proceedings concerned only

one product, an electric cooler-freezer. In rejecting respondent'

argument that the order should be limited to the particuJar prod-vet in question , the Court stated:

\Ve do not agree '\"ith that contention. The Commission has a large discretionin its choice of a remedy .which it deems necessary to cope with the unlawfulpractices found

, * * *

, Commission orders arc not designed to punish for

past transgressions , but are designed "as a means for preventing ilegalpractices in the future.

" * *

'" Petitioners marketed a large number of prod-ucts in commerce. They stand adjudged guilty of the use of ilegal practicesin the advertisement and sale of one product. We think it is entirely reasonab1e for the Commission to frame its orders broadly enough to prohibii peti-tioner s use of identical illegal practices for nn\' purposes or in conjunctionwith the sale of any and all of its products.

See also to the same effect Albert Laue v. 130 F. 2d 48

(9th Cir. 1942) (misrepresentations found to have been made intwo publications were prohibited in any similar publication) ;Consumer s Sales Corp. v. C., 198 F. 2d 404 (2nd Cir. 1952)

(misrepresentations found with respect to aluminum cookwaredinner and silverware, were also prohibited in connection with

the sale of "other merchandise ); and Ben,.",s Watch Co352 F. 2d 313 (8th Cir. 1965), cert. denied 384 U. S. 939

(1966) (misrepresentations found with respect to watches alsoprohibited in connection with the sale of all Benrus products

whether or not related to the watch industry).


1524 Opinion

In the field of drug advertisements it is particularly importantthat the Commission s orders be suffciently broad to ensure thatthe public wil be fully protected against any future misrepresen-tations made by respondents with respect to the entire Jineof pro-prietary preparations which it sel1s and that it not be limited tojust one type of preparation.

Accordingly, it is our judgment that in the circumstances ofthis case and of this respondent , it is essential that the orderwhich we are entering cover all drug products sold by respondent.

B. Respondent' s Representations Respecting Curative Po weTS ofPreprrration H

The order which we are entering prohibits respondent frommaking any general representations which in any way imply thatuse of its products will cure , remove or heal hemorrhoids or hem-orrhoidal tissue. In this connection we have also prohibited re-spondent from representing that its product will shrink hemor-rhoids or hemorrhoidal tissue. We have done so because of ourview that any member of the public who reads a representationthat a product wil shrink hemorrhoidal tissue is unlikely to dis-

tinguish between this representation and the representation thatthe product wil shrink hemorrhoids. Thus , even if it could be lit-erally true under certain circumstances the representation islikely to mislead.

In addition , we have specifically prohibited respondent from re-ferring in its advertising to Bio-Dyne or to any other ingredientseither singly 01' in combination , unless each such ingredient is ef-fective in the treatment or relief of hemorrhoids or any of itssymptoms and unless its specific effect is expressly and truthfullyset forth.

The evidence establishes conclusively that Bio-Dyne, which re-spondent heralded so conspicuously in its advertisement as the " se-cret" of Preparation H , the "magical heaJjng agent" in Prepara-tion H and like representations , had no therapeutic qualities atall so far as hemorrhoids are concerned. The only effect claimedfor "BiD-Dyne" was to "heal" hemorrhoids. Respondent admitsthat its product does not in fact heal hemorrhoids and it is cleartherefore, that any representations as to Bio-Dyne s healing ef-fects are untrue and must be prohibited absolutely. Not only does

Bio-Dyne not heal hemorrhoids but the record is devoid of any ev-idence that it has any therapeutic effect on hemorrhoids.

For the purposes of this litigation respondent arranged to have


Opinion 70 F.

performed a series of laboratory studies for the purpose of dem-onstrating that "Bio-Dyne" stimulates the growth of mouse fib-roblast ceJIs in vitamin-deficient media and increases the meta-bolic rate of tissue ceJIs and explants from rat abdominal tissue(RX 70). However , respondent made no attempt to demonstratethat "Bio-Dyne" would have any effect on ceJIular respiration ofceJIs attached to a living organism. As Dr. Sarner testified:

'" '" '"

(TJhere are many agents that work fine in the laboratory, but be-cause of inhibiting agents encountered in the human body or in any animalbody, these results do not follow on clinical examination (Tr. 443).

Even if it were assumed that this ingredient could increase theoxygen uptake of attached body ceJIs, complaint counsel's wit-nesses unanimously testified that this would have no beneficial ef-fect upon hemorrhoids (Tr. 113 , 114 , 195, 196, 259 , 346 , 416 , 544545 , 610 , 611 , 711 , 712). Respondent attempted to counter this ev-idence through Dr. Arthur GroJIman, a leading pharmacologist.However, after testifying that, if it were assumed that a sub-stance could be demonstrated to increase the oxygen uptake ofbody ceJIs, it could "conceivably" have a beneficent effect on hem-orrhoids (Tr. 1764), Dr. Grollman conceded that hemorrhoids

were not characterized by lack of oxygen (Tr. 1769).Furthermore, the originator of Preparation H, Dr. Sperti

made it very clear in his testimony for respondent that the onlyeffect of adding "Bio. Dyne" to the formula was to offset the de.pressing effect which phenylmercuric nitrate would have on ceJIu.jar respiration and proliferation and thus that it would have nopositive therapeutic value when used in Preparation H (Tr. 956981) .

In view of this evidence , it is clear that any continued referenceby respondent to Bio- Dyne in its advertising would be highly mis-leading and would imply to the public that the presence of thisingredient conveys some therapeutic properties to the product be-yond those specificaJIy claimed.

It is not too much to assume that a member of the public wilbelieve that specific reference in an advertisement to a specific in-gredient must mean that that ingredient is of particular impor-tance to the effcacy of the product. For this reason we believe itis vital in the discharge of our responsibilities to eliminate aJImisleading representations , particularly in the case of drugs , to

prohibit a respondent from singling out a particular ingredient ina medication and by such singling out , without more , convey animpression to the public of the therapeutic importance of such an

A:\ERICAN HOME PRODUCTS CORP. 1629

1524 Findings

ingredient when in fact the ingredient is of no therapeutic valueor of such minimal value as to be virtually worthless.

This is of particular importance in the instant case where re-spondent' s advertisements have accorded major prominence to thepresence in its Preparation H of Bio-Dyne and to its healingproperties. To prohibit respondent from representing that Prepa-ration H has any healing characteristics and to permit it to con-tinue to represent that its products contain Bio-Dyne would be tollu11ify in major part the prohibition respecting the curativeproperties of its products.

C. General Representations of Thempe,dic BenefitsThe order entered by us prohibits respondent from making the

specific representations respecting itch and pain which we havefound to have been false and misleading. The order origina11yproposed by eomplaint counsel would have permitted respondentto make these representations provided it limited them to afford-ing this relief temporarily and in situations where the itching orburning was of a "minor" nature. We believe that an ordercouched in these terms would be ambiguous and diffcult both tocomply with and to enforce. Moreover , any distinctions existingbetween major and minor pain or itch may be definable by medi-cal experts , but it is highly unlikely that such distinctions wouldever be realistica11y appreciated by the hemorrhoidal sufferer ex-periencing the itch or pain. Accordingly, the order entered by ussimply permits respondent to represent what we have found to besupported by the evidence-that use of Preparation H may insome cases afford some temporary relief against some types ofitch Or some types of pain.

We have set aside that portion of the initia1 decision which isinconsistent with this opinion and our Findings of Fact andConclusions which we are entering herein , and have adopted thefindings of fact and conclusions of the examiner which are notinconsistent with our opinion and our Findings of Fact and Con-clusions.

FIJ\DINGS OF FACT , CONCLUSIONS AND ORDER

FINDINGS OF FACT

A. Respondent and Its Product1. Respondent American Home Products Corporation is a cor-

poration organized , existing and doing business under and by vir-tue of the laws of the State of Delaware with its principal offce


Findings 70 F.

and place of business located at 685 Third A venue in the city ofNew York, State of New York (C., Par. 1; Par. 1).

2. Respondent American Home Products Corporation is nowand for more than one year last past has been , engaged in the saleand distribution of preparations offered for the treatment of pilesor hemorrhoids and coming within the classification of drugs asthe term "drug" is defined in the Federal Trade Commission Act(C. , Par. 2; A. , Par. 2).

3. The designations used by respondent for said preparationsthe formulae ' thereof and directions for use are as follows :

(1) Designation: " Preparation H" Ointment.

Formula: The active ingredients for Preparation H Ointment are asfolIows:

Live Yeast CeJl Derivative , Supplying 2 000 units, Skin RespiratoryFactor (Bio Dyne) Per Ounce of Ointment; Shark Liver Oil 3. 0%; Phen-ylmercuric Nitrate 1 :10 000 in a base composed of petrolatum , lanolin

faIba , mineral oil and oil of thyme.Directions: Remove new protective cover. Apply freely night and

morning and after each bowel movement. Lubricate applicator beforeeach application and thoroughly cleanse after use. Rectal condi6ons aremore rapidly improved by continual application. CAUTION: In case ofbleeding, a physician should be consulted. Keep all medicines out of thereach of children.

(2) Designation: " Preparation H" Suppositories.Formula: The active ingredients are Live Yeast Cel! Derivative

supplying 2 000 units , Skin Respiratory Factor (Bio Dyne) Per Ounce ofSuppository Base; Shark Liver Oil; 3.0% Phenylmercuric Nitrate1 :10 000 in a base made up of cocoa buttcl' , beeswax , polyethylene glycol600 dilauratc , and glycerin.

Directions: Remove wrapper and insert one suppository morning andnight and after each bowel movement. Rectal conditions are more rapidly

improved by continual application. CAUTION: In case of bleeding, aphysician should be consulted.

(C. , Par. 2; A., Par. 2; CX 5-8; RX 9-10; Stipulation , Tr. 68; Tr.1017-19. )

4. Respondent American Home Products Corporation causesthe said preparations , when sold, to be transported from itsplaces of business located at 1000 South Grand Street , Hammon-ton , New Jersey, and 1919 Superior Street, Elkhart, Indiana, topurchasers thereof located in various other States of the United

States and in the District of Columbia. Respondent maintainsand at an times mentioned herein has maintained, a course of

1 The quantita.tive formulae for Preparation Hare tTlde secrets andevidence as in camera exhibits (CX 7 , 8: Tr. 92- 97).

were received in


1524 Findings

trade in said preparations in commerce, as j'commerce" is definedin the Federal Trade Commission Act. The volume of business insuch commerce has been and is substantial (C. , Par. 3; A. , Par.3).

B. Representations Made5. In the course and conduct of its said business , respondent

has disseminated , and caused the dissemination of, certain adver-tisements concerning the said preparations by the United Statesmails and by various means in commerce , as "commerce" is de-fined in the Federal Trade Commission Act , including, but notlimited to , advertisements inserted in newspapers , magazines , andother advertising media, and by means of television and radiobroadcasts transmitted by television and radio stations located inthe District of Columbia and in various States of the UnitedStates , having suffcient power to carry such broadcasts acrossstate lines , for the purpose of inducing and which were likely toinduce, directly or indirectly, the purchase of said preparations;and has disseminated , and caused the dissemination of, advertise-ments concerning said preparations by various means, inc1uding,but not limited to , the aforesaid media for the purpose of induc-ing and which were likely to induce, directly or indirectJy, the

purchase of said preparations in commerce , as "commerce" is de-fined in the Federal Trade Commission Act (C. , Par. 4; A. , Par.4).

6. Among and typical of the statements and representationscontained in the advertisements disseminated as set forth in the

foregoing paragraph are the following:

Radio CommercialHemorrhoid sufferers.

. .

the proof is here! Proof of dramatic new reliefof swollen injured tissue! Proof from doctors. from clinics.. fromhospitals.

Yes, doctors report a new healing medication. PreparationH . . . actual1y shrinks hemorrhoids without surgery. Tests in famous hospi-tals and clinics reveal: Preparation H relieves pain promptly-heals injuredtissue. The secret? Only Preparation H has the new wonder substance that\ve call Bio-Dyne to draw the body s own healing oxygen to the painful area.Here are the dramatic resu1ts: One-Preparation H relieves pain and itchingpromptly. Two-Preparation I- heals injured tissue. And three-PreparationH shrinks hemorrhoids.

. .

without astringents , narcotics , or surgery.

. .

even in cases of t\1.renty years ' suffering. Yes , the proof is here-proof of theprompt relief of painful hemorrhoids. Get clinically tested, hospital tested

Preparation H (optiona1: Ointment or Suppositories). Preparation H . . .shrinks hemorrhoids without surgery!

1632

Findings

FEDERAL TRADE COMMISSION DECISIONS

70 F.

TV CommercialVIDEO

OPEN MS MAN SEATED AT DESK.HE REACHES FOR BOOK FROMBOOK- SHELF BEHI:\D HIM.

OPENS BOOK TOWARD AUDENCE , RESTS IT VERTICALLY0)\ DESK BEFORE HIM.

CUT TO OPEN BOOK. SEECHAPTER TITLE: " SHRIKKSHEMORRHOIDS WITHOUTSURGERY.

PKG. OF PREPARATION H MOVESFORWARD OUT OF TEXT TOMAXD!UM WIDTH SO PRODUCTNAME , CHAPTER HEADLINEBOTH ARE LEGIBLE.

CUT BACK TO MAN. HE REFERSTO BOOK.

PAN AS MAN TURNS TO HISRIGHT. TAKES PIPETTE OUTOF RACK . HOLDS IT UP OVEREMPTY TEST.TUBE.

CUT TO ECU GLISTENING DROPHA)\GING FROM PIPETTE.SI;PER TITLE: " BIO.DYNE"AT BOTTOM SCREEN.

AUDIO

ANJ\ CR. DIRECT: These aredoctors ' reports on hemorrhoids. . .revealing a new medicationthat relieves pain and itchingpromptly, heals injured tissue. . .

AN"NCR. , OVER. . . . and actuallyshrinks hemorrhoids without

surgery.

It' s the new medical discovery,Preparation H. Clinically testedhospital tested , Preparation

ANNCR., DIRECT: Yes, hospital

tests and clinical tests now showprompt relief of pain. . . healingand shrinking of swollen, injuredtissue.

The secret'? Only Prepartion Hcontains Bia-Dyne . .

ANKCR. , OVER: . . . theremarkable substance that draws

the body s own healing oxygen

to the painful area.

Car CardsCLINICAL TESTS SHOW PREPARATIOK H SHRINKS

RHOIDS WITHOl;T SI!RGERY. RELIEVES PAIN- . STOPSSHRINKS PILES.

HEMOR.ITCHING

Periodical AdvertisingSCIENCE SHRINKS PILES NEW WAY WITHOUT SURGERY STOPS

ITCH-RELIEVES PAIN.Preparation H- The 0111y Hemonhoidal Remedy In 'Vorld Thai Contains

New Healing Substance.Every Claim Verified By Doctors and Proved By 4 Leading Clinics.For the first time sciencc has found a new healing substance with the as-


1524 Findings

tonishing ability to shrink hemorrhoids , stop burning rectal itch and relievepain-without surgery or painful injections.

In one hemorrhoid case after another prompt relief was reported-also astriking improvement" in from 2 to 4 days. These reports were verified by a

doctor s observations and proved by four leading clinics.Pain and itching were promptly relieved. And while gently relieving this

distress-actual reduction (shl'inking) of hemorrhoids took place. Most amaz-ing of all-this improvement was maintained in cases where a doctor s obser-

vations were continued over a period of many months!In fact , results were so thorough that sufferers were able to make such as-

tounding statements as " Piles have ceased to be a problem!" And amongthese sufferers where a wide variety of hemorrhoid conditions some of 10 to20 years ' standing.

All this was accomplished at home ' without surgery, injections , narcotics orastringents of any kind. The secret is a new healing substance (Bio Dyne)-the discovery of a \Vorld famous research institute. This new healing sub-stance is offered in ointment or convenient 8upposit01"Y form. called Prepa?'tion H, And Preparation H is the onl'Y hemorrhoidal remedy in the world con-taining this b'u1y magical healing substance.

ilIa.gic Healing Powe?'Discovered by Accident

Like many great discoveries-the effectiveness of Preparation H was alsodiscovered quite by accident, In the laboratories of a famous research institu-

tion in Cincinnati , Ohio-renowned scientists were conducting advanced med-ical tests.

During an ether-extracting procedure , there was a sudden explosion. Anassistant was severely tJUl'ned. As an emergency measure , large quantities ofan ointment (still in an experimental stage) were smeared on. To everyonearnazement-pain ceased immediately and the skin healed remarkably fast'',ithout scarring.

Later tests revealed this ointment was full of a ne,v substance which hasthe astonishing power to heal iniured skin. This substance was then scientifi-cally combined '',ith other effective medical ingredients into a product calledPreparation H, And here s ,vhy this remarkable hemorrhoid remedy is so suc-cessful-Preparation I-I promptly relieves pain and burning rectal itch.Shrinks hemorrhoids without surgery. Heals injured tissue back to normal

and helps prevent infection of hemorrhoids.

Every claim made for Preparation II has been verified by doctors. This isthe only hemorrhoidal remedy cont.aining Bio-Dyne. Just ask for PreparationII at any drug counter in ointment or suppository form.(CX 9-14; RX 21 , 22; Tr. 1917).

C. Meaning of RepTesentations Made7. Through the use of advertisements set forth in paragraph 6

hereof and others similar thereto not specifically set out thereinrespondent has represented and is now representing, directly andby implication , that the use of Preparation H Ointment and Sup-positories , and each of them will :


Findings 70 F.

(a) Reduce or shrink hemorrhoids;

(b ) Avoid the need for surgery as a treatment for hemmor-rhoids;

(c) Eliminate all itch due to or ascribed to hemorrhoids;(d) Helieve all pain attributed to or caused by hemorrhoids;(e) Heal , cure or remove hemorrhoids , and cause hemorrhoids

to cease to be a problem.

D. Evidence Pertaining to Truthfulness of Claims Made

8. The following medical experts , all of whom were proctolo-gists, or specialists in diseases affecting the anus, rectum andlower colon , including hemorrhoids (Tr. 102 , 185-186, 248 , 336,409-410 478 536-537 601 695), testified on the basis of their ex-periences in their practices with the treatment of hemorrhoidsand on the basis of their general knowledge in the the field of theirspecialty:

(a) DT. Richa,.d Hopping: formerly Chief of Proctology, Be-

thesda Naval Hospital and presently President of the MedicalBoard and Chief of Proctologic Services , Saint Barnabas MedicalCenter, ="ewark , New Jersey; author or a number of articles ondisorders of the anus, rectum and lower colon (CX 28) .

(b) Dr. Sylvan Manheim.: formerly chief of the Rectal ClinicMount Sinai Hospital New York , New York and Clinical Profes-sor of Surgery for Rectal Diseases , :!ew Y ork 1edical College;

presently, Consulting Proctologist , Mount Sinai Hospital. Authorof the bool( "Proctology, " published by Oxford University Pressin 1943; co-author of a number of articles in the field (CX 29).

(c) D,' . W. MaTtin MaTino: Chief , Department of Surgery, Di-vision of General Surgery, Division of Proctology, The Brooklyn-Cumberland Medical Center (CX 30).

(d) D,' . Samuel W. EisenueTg: Clincial Professor of Proctol-

ogy, Temple University Medical Center (CX 31).(e) Dr. Joseph B. Sarner: Senior Attending Proctologist, Ein-

stein Medica! Center, Philadelphia; instructor in proctology at

Graduate School of Medicine , University of Pennsylvania (CX32) .

(f) D1" Andrew J. j,lcAdams: Chief of Department of Proctol-ogy, Division of Surgery, Western Pennsylvania Hospital (CX33) .

(g)

Dr. KaTI Zimmerman: formerly President of the Ameri-2 The ,,"ords " hemorrhoids" find " piles" are synonymous (See Finding 15 infra) and will be

used interchangeilbly herein.


1524 Findings

can Protologic Society, author of over 30 articles and papers inthe field (CX34).

(h) . ChaTles Evans Pope: Head of the Proctologic Depart-ment, St. Francis Hospital , Evanston , Ilinois; author of 30 pa-pers and articles in the field (CX 35).

(i) Dr. Dumnd Smith: Chief of the Surgical Rectal-Proctos-copy Clinic at J\ orthwestern University Medical School (CX 37).

9. The fol1owing medical experts testified for respondent withrespect to clinical studies which they had conducted of Prepara-tion H and on the basis of their experiences in their medical prac-tices with Preparation H , other ointments and suppositories andother methods of treating hemorrhoids;

(a) Dr. Robert E. S. Young: General surgeon; instructor insurgery at Ohio State University; director of the Institute ofMedical Research , Inc. of Columbus , Ohio (RX 79).

(b) DT. Olin BUTt: Obstetrician and gynecologist; Fel10w ofthe American College of Obstetricians and Gynecologists (Tr.1514-1517) .

(c) Dr. Jerome Epstein: Specialist in internal medicine andgastroenterology; Assistant Clinical Professor of Medicine atGeorgc Washington University School of Medicine; formerly aN ew Drug offcer" with the federal Food and Drug Administra-

tion (Tr. 1540-1541; RX 80).(d) Dr. Normnn H. Isan.cson: Surgeon , who , according to his

tcstimony had a "spccial interest in Proctology: " Clinical In-structor at George Washington University Medical School (Tr.1653 , RX 81).

(e) Dr. Donald Berko"Witz: Specialist in gastroenterology; As-sociate Professor of Medicine at Hahnemann Medical Col1ege; at-tending in Gastroenterology at the Albert Einstein and Sidney

Hinman Medical Centers in Philadelphia; holder of Master ofScience and Master of Arts Degrecs in biochemistry; author ofnumerous articles on a variety of medical subjects (Tr.1075- 1080; RX 76).

(f) DT. Willin.m Lieberman: Proctologist; Director of Depart-ment of Proctology, Unity Hospital , Brooklyn, :!ew York; Fel10wand President Elect of International Academy of Proctology; au-thor of numerous articles in the field of proctology (Tr.1219-1224; RX 77).

(g)

Dr. HaTold S. Feldman: General practitioner, with em-phasis on internal medicine and psychosomatic medicine; holderof Doctorate in Philosophy on 2Vledicine Sciences with Major in

1636 FEDERAL TRADE CO:\MISSION DECISIONS

Findings 70 F.

Pharmacology; Clinical Instructor at New York Medical Co11egeand instructor in Psychopharmacology at Seton Ha11 Medical

School (RX 72; Tr. 887-891).(h) D?". F,'ed J. Phillips: General practitioner; associate with

two other general practitioners and a surgeon at Quakertown , Pa.(Tr. 835-843).

(1) Dr. FredeTick Steigman: Specialist in internal medicine

and gastroenterology; Associate Clinical Professor of Medicine atUniversity of Ilinois Co11ege of Medicine and Professor of Gas-

troenterology of Cook County Graduate School of :V1edicine (RX71; Tr. 808-813) .

The fo11owing medical expert testified for respondent on thebasis of his knowledge as a pharmacologist:D?". A ,. thu,' Grallman: Professor of Medicine and Chairman ofthe Department of Experimental Medicine at Southwestern Medi-

cal School of the University of Texas; author of "Pharmacologyand Therapeutics" (6th Ed. 1965 (Tr. 1769J), a leading text , andnumerous other books and publications (RX 83).

10. Evidence was submitted by respondent pertaining to threcclinical studies , each of which had been conducted at the requestof respondent:

(a) Dr. Robert Young, who , assisted by Dr. Olin Burt, con-ducted a clinical study of Preparation H with 127 patients during1958 and 1959.

(b) Dr. Jerome Epstein and Dr. Norman Isaacson , who , work-ing independently of each other , each conducted a clinical studyof Preparation H with 119 of their hemorrhoid patients during1961-62.

(c) Dr. Donald Bcrkowitz and Dr. Wi11iam Lieberman whoconducted separate clinical studies during 1963-54 on 196 pa-tients, approximately half of whom used "Anusol " an ethicalhemorrhoidal preparation , as a control.

These clinical stud' es are described in Findings 11 , 12 and 13.

11. Y rmng-Snrt Study

Of the 127 patients in the study, 19 were pregnant women whowere treated in whole or in part by Dr. Burt, and the balance

were treated by Dr. Young. Each patient participating in thestudy was told by Dr. Young or Dr. Burt that it was a clinicalinvestigation and that he did not know whether the productwould be of value or not. The patients were not told what theproduct was although the doctors did know that they were testing

AMERICAN HOME PROD1.CTS CORP. 1637

1524 Findings

Preparation H (Tr. 1456). The patients were instructed to use themedication after each bowel movement and at night when theywent to bed. They were also instructed not to use any other typeof medication or treatment. After the initial visit, the patient wasseen again in three or four days and at intervals thereafter unti

there was no further need for observation. The report forms werebroken down into various items: "Chief Complaint

" "

DiagnosisFollow Up,

" "

Reactions" or " S'2Dsitivity " and "Comments. " Noinformation was recorded respecting the patients ' medical histo-ries, previous medication used, the types of examinations per-formed or the size or state of the patient' s hemorrhoids. 1'0 controlwas used. Of the patients who participated, 13 did not havehemorrhoids but had some other anal or rectal disorder (RX

, 5P, 5V, 5Z8, 5Z10, 5Z13, 5Z18, 5Z28, 5Z31 , 5Z33, 5Z355Z57 and 5Z74). The study could not be completed on 13cases due to failure to contact or death (RX 5L , 5Z12 , 5Z15 , 5Z175Z25 , 5Z32 , 5Z36 , 5Z37 , 5Z38 , 5Z41 , 5Z42 , 5Z63 , 5Z69). Twenty-nine of the patients were examined by other doctors (Tr. 1489).

12. Epstein-l saacson Studies

Dr. Epstein s study involved 33 subjects who were patients inhis private practice. Each patient was told that the doctor wasevaluating some hemorrhoidal preparations which were com-pletely safe , but were not informed as to the name of the drug; hewas put on the doctor s usual , conservative program and was in-structed by the doctor to use the preparation morning, evening,

and following each bowel movement. The records show that eachpatient made either two or three visits after the initial examina-tion , usually about a week apart (RX 6A-6Z7). 1'0 control wasused in the study. Dr. Epstein reported that of the 33 cases, 1 wasreferred for surgery (RX 61') ; 6 did not have hemorrhoids (RX6J, 6K , 6L , 6:11 , 6Z2 , 6Z3) ; 7 were free from symptoms on thefourth visit (RX 6A , 6C, 6-0, 6X , 6Z , 6Z1 , 6Z5) ; 12 still hadsymptoms on the fourth visit (RX 6E , 6D , 6G , 6H , 6I , 6P , 6Q, 6R

, 6V , 6Z4 , 6Z6) ; 5 did not complete the test (RX 6F , 6T, 6U,

, 6Z7) ; 2 others with hemorrhoids did not complete the testsince they claimed they were cured (RX 6E , 6W) .

Dr. Isaacson s study consisted of 86 cases. The patient was nottold the name of the ointment or suppositories which he wasgiven but was advised that the medication was " reported to be

pretty good" (Tr. 1661). The patient was instructed to apply themedication morning, evening, and after each bowel movement

1638 FEDERAL TRADE COMMISSIO:\ DECISIONS

Findings 70 F.

(Tr. 1662) ; Dr. Isaacson also prescribed a diet and bowel softener(Tr. 1675). The records show that each subject was trcated twoto four times following the initial visit, sueh visits usuaJIy beingspaced three to seven days apart (RX 6Z8-RX 6Z93). No controlwas used in the study. Of the 86 cases Dr. Isaacson found that 26(RX 6Z8 , 6Z10 , 6Z13, 6218 , 6Z19 , 6Z21 , 6223, 6Z24 , 6Z29 , 62356241 , 6242 , 6243 , 6245, 6246 , 6Z49 , 6255 , 6258 , 6260 , 6Z62, 6Z646Z66 , 6269 , 6271 , 6278 , 6280) required surgery. In addition , 4 pa-tients reported "no improvement" in their symptoms (RX 6296Z16 , 6Z20 , 6Z28) and 5 others stiJI had some symptoms at theend of the study (RX 6Z31 , 6Z36, 6Z37 , 6Z40 , 6Z47).

13. BeTkowitz-Lieberman StudiesDr. Berkowitz and Dr. Leiberman were requested by respon-

dent and paid a fee of $7 500 each to conduct a test comparingPreparation H ointments and suppositories with "Anusol " an-other preparation for hemorrhoids. The study was said to bedouble blind " in that the doctors were not told which of the ap-

plications were Preparation H and which were Anusol and thepatients were not given any information as to the identity of theitems. The products , however , differed in color (Tr. 1105-1106).In Dr. Berkowitz ' study 54 patients were treated with Prepara-tion H , and 42 treated with AnusoJ. In Dr. Lieberman s study 48were treated with Preparation Hand 52 were treated with Anu-soL Dr. Berkowitz also prescribed /lother therapeut.ic measures,such as hygiene , diet , sitz baths , stool softeners" (Tr. 1107). Dr.Lieberman told each patient to continue with whatever course oftreatment he had previously been giving himself.

Each of the doctors was requested to observe the patients dur-ing 3 visits. In Dr. Berkowitz ' study the visits generaJIy covered a14-day period. In Dr. Lieberman s study the span of the studygeneraJIy exceeded this period; the total period was in every caseexcept one less than 30 days, although one case spanned 4months.

The results obtained from the use of Anusol were similar tothose obtained from the use of Preparation H (J.D. , p. 1.590). Ofthe 48 patients in Dr. Lieberman s group who used Preparation, 9 received surgical treatment (RX 80, 8Z75, 8Z81 , 8Z95,

8Z101 , 8Z107 , 8Z123 , 8Z145 , 8Z149), and 3 more needed it but didnot receive it (RX 8266 , 8Z133 , 8Z143), and all but 5 (RX 85,8Z31 , 8235 , 8273 , and 8293) stiJI had some symptoms at the endof the study.


1524 Findings

E. General Medical Facts PeTtaining to HeraoT,.hoids and thei,.T1' eatment

14. "Hemorrhoids " are masses of dilated weak-wa1led veins lo-cated underneath the mucous membrane of the lower portions ofthe rectum and under the skin of the anal canal and the peri-analarea (Tr. 193 , 255 , 340 , 413-414 , 478 , 543, 606 , 709 , 817 , 838, 867892).

15. The terms "hemorrhoids" and "piles" are synonymous (Tr.117 193 255 340 414 478-479 543, 607 and 709).

16. "Internal hemorrhoids" are hemorrhoids occurring abovethe pectinate line and are covered by mucosa. "External hemor-rhoids" are hemorrhoids occurring below the pectinate line andare covered by skin (Tr. 110 , 193, 199 , 232 , 236 , 255-257 , 262

342 420 421 486 548 549 608, 609 817 838 867 and 892).

17. An "extcrnal thrombotic hemorrhoid" is a blood clot underthe surface of the skin located in the immediate vicinity of theanal opening (Tr. 117). It is also referred to as an "anal hema-toma" (Tr. 719) or a "perianal thrombosis " (Tr. 549).

18. A "proJapse" or "prolapsing hemorrhoid" is an internalhemorrhoid which, due to laxity of the rectum is enabled to fa1loutside the anal canal and protrudes to the surface (Tr. 199).

19. Hemorrhoids develop in a human being largely because ofthe fact that he stands in an upright position. In such a position a

column of blood is formed from the splenic to the superior hemor-rhoidal vein. The hemorrhoidal veins do not have valves to sup-port the weight of this column of blood. The resulting pressure

causes the hemorrhoidal veins to dilate (Tr. 594 , 231). Hemor-rhoids tend to be hereditary (Tr. 144 , 231). Other factors leadingto the development of hemorrhoids are abnorma1ly long periods

of standing, straining, diffculty with bowel movement , impactedstool , pregnancy and cirrhossis of the liver (Tr. 231-232 , 144).

20. The most common symptom of internal hemorrhoids isbleeding (Tr. 256 , 393, 479). The other principal symptom of in-ternal hemorrhoids is prolapse (Tr. 256). Pain rarely occurs in

internal hemorrhoids since the sympathetic nervous systemwhich services the region above the pectinate line where hemor-rhoids are located does not contain sensory nerve fibers (Tr. 266

294 , 342-343). Pain , however , may occur in infrequent cases ofsevere complicated internal hemorrhoids as the result of spasm orstrangulation caused by prolapse or as the result of the involve-ment of tissues beyond the pectinate line (Tr. 342 , H5 , 631-632

723) .

1640 FEDERAL TRADE COM""ISSION DECISIONS

Findings 70 F.

21. The most common svmptoms of external hemorrhoids arepain and swelling (Tr. 256 , 742). Pain in external hemorrhoids isfrequentJy caused by an external thrombotic hemorrhoid (Tr.503). Other eauses of pain in external hemorrhoids are inflamma-tion , swelling and ulceration (Tr. 174 , 267 , 358 , 519). Pain mayalso result from infection. However , this cause of pain is a rela-tively infrequent occurrence since the rectaJ and anal area is rela-tively highJy resistant to infection (Tr. 520) and thus infectionoccurs very rarely as a symptom of hemorrhoids (Tr. 315).

22. Swelling, as distinguished from the dilation of the hemor-rhoidal veins , may be a symptom of hemorrhoids as well as a pos-sible cause of pain in external hemorrhoids. Swelling usually

results either from a blood clot or thrombosis, which causes dis-tension in the tissue overlyin.o: the hemorrhoid, or from edema,

which is the accumulation of serous fluid in the interflbrilarspaces in such tissue (Tr. 144 550).

23. Itching is not a common s?mptom of internal or externalhemorrhoids (Tr. 129 , 265 , 618-619 , 727). The itching thought tobe caused by hemorrhoids is usually the result of some other con-dition such as fungus infection or idiopathic pruritis (Tr. 326

502. ,")04 , 347 , 618-619 , 727). The itching which is caused by hem-orrhoids is usuallv the result of discharge from a proJapsed inter-nal hemorrhoid (Tr. 318 , 425 , 618-619), or heaJing of an externalhemorrhoid (Tr. 265, 5(2).

24. The symptoms of hemorrhoids can be confused with otherconditions such as fissure, fistula , perianal or peri-rectal abcesshypertrophic papillae , papilitus , cryptitis , polyps , proctitis, ul-

ccrative colitis , pl'uritis ani and carcinoma (cancer). Any of theseconditions can co-exist with hemorrhoids and it is not uncommonlo fmd sueh a situation (Tr. 114-115, 196-197 205 259-260347-349 , 483-484 , 545-546 , 612-613 , 714-715).

25. The symptoms of hemorrhoids often disappear spontane-ously \vithin short periods of time , which may range from severalnays to two weeks (Tr. 119, 264 , 324 , 255 , 361 , 424 , 875, 1613).However , the underlying pathology, namely, the vascular dila-tion , ,vill persist un1ess corrected and will be subject to recurringepisodes of symptoms (Tr. 516 , 214).

26. Surgical removal is the on1y means by \vhich hemorrhoidscan be permanently curen (Tr. 118-119 , 195 , 200-202, 262-263352 422 487 550 554 623, 719-723, 830). However , surgery doesnot effect a complete cure in every case (Tr. 150). Surgery maynot be advisable or necessary in every case. Surgery may


1524 Findings

contra-indicated in cases in which the patient's general medicalcondition is such that the danger of anesthesia and surgery out-weigh the possible benefits to be derived (Tr. 226). Surgery is alsonot advisable for a simple, uncomplicated hemorrhoid ('11' 169).Although hemorrhoids may be uncomfortable they are rarely avery serious medical problem , so that a patient, if he chooses toavoid surgery or should avoid it for medical reasons, can go

through life without having his hemorrhoids removed (Tr. 135).27. The symptoms of simple, uncomplicated, internal hemor-

rhoids of small size can frequently be ameliorated by in.i ectionaltherapy. This consists of the in.iection of a schlel'osing solutioninto the hemorrhoid itself which causcs scar tissue to form whichcuts off the blood vessel fceding the hemorrhoid (Tr. 145 , 200,

262-263 , 353). A further treatment which has becn uscd withinthe last several years is the baron ligation method whereby a li-gature of rubber is placed around internal hemorrhoids as an-other means of cutting ofT blood circulation to the hemorrhoid(Tr. 200-201 , 488).

28. In cases in which surgery, in.iectional therapy OJ' the baronligation method are not used, a so-called "conservative " course oftreatment may be prescribed. The measures used in such a courseof treatment include cleanliness , altering of the diet to eliminate

irritative foodstuffs, control of the bowels to ensure a smooth

soft stool , warm baths , witch hazel , boric acid , local anestheticointments , supposito1'ies , avoidance of standing and manual rein-sertion of prolapse ('11' 120 , 202 , 306 , 356-357 , 684-6R6). Oint-ments and suppositories contain lubricants which may protect theanal and rectal canal against the passage of hard , dry stoo1. Suchlubricants may also serve to relieve dryness and soften the skinas well as provide a psychological advantage; many people derivemental relief from the fact that some sort of treatment is applied

(T1' 203-204 , 279 , 313 , 355 , 358 , 362-363 , 52 557).

F. Q'l"eclients in P"epamtion H

29. The active ingredients set forth in the Preparation H for-mula consist of (a) a " live yeast cell derivative supplying 2 000units Skin Respiratory Factor (Rio-Dyne) per ounce " of ointmentor suppository base; (b) Shark Liver Oil and (c) PhenylmcrcuricNitrate 1: 10 000, in a base composed of various lubricants andother materials which were included in the formula to make itpossible to incorporate the other ingredients in the formula (F. 3;Tr. 953-954).


Findings 70 F.

(a) Live Yeast Cell Derivative

" ("

Bio-Dyne

The substance "Bio-Dyne" was first isolated in the 1930's in thelaboratories of the Institutum Divi Thomae of Cincinnati in thecourse of research directed by Dr. George Sperti. Later it was in-corporated in a topical ointment-identical to the Preparation Hointment-which was patented in 1943 and subsequently mar-keted for the treatment of burns and wounds.

Bio-Dyne" consists of amino acid , mineral salts and pantoth-enic acid (RX 70A). It was added to the formula for the purposeof offsetting the depressing effect which , it was felt, that phenyl-mercuric nitrate would otherwise have on cellular respiration andproliferation (Tr. 956, 980-981 , 988). Laboratory experimentshave demonstrated that when applied in pure form in test tubes itmay under certain conditions increase the oxygen uptake and thecellular growth of mouse and rat cells in vitamin deficient media(RX 70A). However , neither oxygen deficiency nor vitamin defi-ciency plays a part in the causation or aggravation of hemor-

rhoids (Tr. 111 , 194 , 257-258 , 345, 416 , 480 , 543-544 , 609 , 711

1767-1769). Furthermore , hemorrhoids are not caused by a defi-ciency in the body cells of pantothenic acid , amino acids or nub'i-tion (Tr. 1767).

(b) Shark Liver OilShark liver oil was added to Preparation H as another source of

Bio-Dyne" (Tr. 953; F. 29 (a) ). It is also a source of Vitamins Aand D (Tr. 1762). However , vitamin deficiency does not playapart in the causation or aggravation of hemorrhoids (F. 29 (a),s"pm). This ingredient may also serve as a lubricant and tends tohave an antiseptic action (Tr. 1762).

(c) Phenylmercuric NitrateThis substance is a bacteriostatic agent which is not recognized

as a potent antiseptic (Tr. 298). It may perhaps assist in protec-tion against infection (Tr. 464) although due to the fact that thesubstance is mixed with other fluids in the rectal tract , it may bediluted to the point where it has no effect (Tr. 463-464).

30. Preparation II Ointment and Suppositories do not containan astringent , anesthetic or anti-pruritic (itch relieving) agent(CX 5C; Tr. 278).


1524 Conclusions

G. Conclusions Te Effect of Preparation H on Hemo"Thoids and

Its Symptoms and Manifestations31. Preparation H wil1 not avoid the need for surgery where it

is indicated, or heal , cure or remove hemorrhoids , or cause hem-orrhoids to cease to be a problem (F. 25 , 26 , 28, 29; I.D. , p. 1602;conceded by respondent on appeal herein).

32. Preparation H cannot reduce the size of hemorrhoidal veins(Tr. 128-129, 173-174, 212-213, 276, 369-370, 436-437, 500663-564 , 629-630 , 740 , 1497 , 1668).

33. Preparation H may possibly, through the lubricants whichit contains , temporarily protect inflamed surface areas from thepassage of hard , dry stool and thereby have some effect uponedema or swel1ing in the tissue overlying hemorrhoids (Tr. 2021471 , 1570 , 1668. But cf. Tr. 128-129 , 463 , 684 , 742-143). How-ever, where swel1ing is due to thrombosis (1'1' 264), it wil haveno beneficial effect (Tr. 503).

34. Preparation II may in some cases afford some temporaryrelief against some types of pain associated with hemorrhoids(Tr. 131 , 207, 279, 372-373 , 439-440, 603 , 566, 632-633 , 744).

Through the lubricants which it contains, this medication mayprotect inflamed surface areas against the passage of hard, dry

stool and thereby temporarily relieve some pain caused by ulcera-tion or from edema or swel1ing resulting from such inflammation(Tr. 174 , 212-213 , 358, 493 , 525. But cf. Tr. 128-129 , 463 , 684

742-743). Preparation H can , however , have no effect upon paindue to thrombosis (Tr. 295 , 358 , 503) or due to spasm or strangu-lation caused by prolapsing internal hemorrhoids '(Tr. 631-632).

35. Through the lubricants which it contains , Preparation Hmay possibly relieve dryness and surface irritation and therebyprovide some temporary relief from some types of itching asso-ciated with hemorrhoids (T1' 131, 215, 279-280, 373-374439-440 , 503-504 , 566 , 633-634 , 741) .

36. Except for the effects set forth in F. 33, 34 , 35 , as wel1 aspossible psychological effects (see F. 28), Preparation H wil not

have any beneficial effect in the treatments or relief of hemor-rhoids or any of its symptoms (T1' 131 , 215, 279, 315-316372-373 , 424 , 439-440 , 503-504 , 566 , 632-633, 682-683, 744; An-swer, Par. 3) .

CONCLUSIONS RE ALLEGATIONS II\ COMPLAINT

1. The Federal Trade Commission has jurisdiction of the sub-ject matter of this proceeding and of respondent.


Order 70 F.

2. Through the use of the advertisements set forth in para-graph 6 hereof and others similar thereto not specifically set outtherein , respondent has represented and is now representing, di-rectly and by implication , that the use of Preparation H Ointmentand Suppositories , and each of thcm , wil:

(a) Reduce or shrink hemorrhoids;

(b) A void the need for surgery as a treatment for hemor-

rhoids;(c) Eliminate all itch due to or ascribed to hemorrhoids;(d) Relieve all pain attributed to or caused by hemorrhoids;(e) Heal , cure or remove hemorrhoids , and cause hemorrhoids

to cease to be a problem.3. Preparation H Ointment or Suppositories wil not:(a) Reduce or shrink hemorrhoids;

(b ) Avoid the need for surgery as a treatment for hemor-rhoids;

(c) Heal , cure or remove hemorrhoids and cause hemorrhoidsto cease to be a problem;

(d) Eliminate all itch or pain due to or ascribed to hemorrhoidsor afford any relief from pain or itching associated with hemor.rhoids in excess of affording some temporary relief in some casesof pain and itching associated with some types of hemorrhoids; or

(c) Afford any other type of relief or have any other therapeu-tic effect upon hemorrhoids or upon any of the symptoms or man-ifestations thereof.

4. Therefore , the advertisements referred to in paragraph 6hereof were and are misleading in material respects and consti-tuted and now constitute "false advertisements" as that term isdefined in the Federal Trade Commission Aet; and the dissemina-tion of said false advertisements constituted , and now constitutesunfair and deceptive p1'actices in commerce , in violation of Sec-

tions 5 and 12 of the Federal Trade Commission Act.

ORDER

I. It is ordered That respondent American Home ProductsCorporation, a corporation, and its offcers, representativesagents and employees , directly or through any corporate or otherdevice , do forthwith cease and desist from disseminating or caus-ing the dissemination of any advertisement by means of theUnited States mails or by any means in commerce , as " commerceis defined in the Federal Trade Commission Act:

AMERICAN HOME PRODCCTS CORP. 1645

1524 Order

A. In connection with the offering for sale , sale or dish'i-bution of Preparation H Ointment or Suppositories Ol anyother product offered for sale for the treatment or relief ofhemorrhoids or piles or any of its symptoms which:

1. Represents directly or by implication that the use

of such product wil1:(a) Reduce or shrink hemorrhoids or hemorrhoi-

dal tissue or membranes or reduce or shrink swell-ing associated with hemorrhoids;

(b) Avoid the need for surgery as a treatment

for hemorrhoids or hemorrhoidal symptoms;(c) Heal , cure or remove hemorrhoids or elimi-

nate the problem of hemorrhoids;(d) Afford any relief from pain or itching attrib-

uted to or caused by hemorrhoids in excess of af-fording some temporary relief in some cases of painand itching associated with some types of hemor-rhoids;

(e) Afford any other type of relief or have anyother therapeutic effect upon the condition knownas hemorrhoids or upon any of the symptoms or

manifestations thereof.2. Contains any reference (a) to the word "Bio-

Dyne ; (b) to any word which implies that said productwil1 shrink hemorrhoids; or (c) to any word which im-plies that said product wi1 provide any relief from painor itching associated with hemorrhoids in excess of af-fording some temporary relief in some cases of pain anditching associated with some types of hemorrhoids.

3. Contains any reference to any other ingredienteither singly or in combination unless each such ingre.dient is effective in the treatment or relief of hemor-rhoids or any of its symptoms and unless the specific ef-fect thereof is expressly and truthful1y set forth.

B. In connection with the offering for sale , sale or distri-bution of any "drug" within the meaning of the FederalTrade Commission Act, ineluding without limitation anyproduct referred to in Paragraph j (A) hereof , which misrep-resents directly or by implication the effcacy of such drug.

C. Disseminating, or causing to be disseminated, by any

means , for the purpose of inducing, or which is likely to in-duce , directly or indirectly, the purchase of respondent'


Final Order 70 F.

preparation or preparations , in commerce , as "commerce" isdefined in the Federal Trade Commission Act , any advertise-ment which contains any of the representations prohibited inParagraphs I (A) and I (B) hereof.. In the event that respondent at any time in the future mar-

kets any preparation for the treatment or relief of hemorrhoidsor any of its symptoms for which it desires to make any of the,.-epresentations now prohibited under Paragraph I (A) of thisorder , it may petition the Commission for a modification of theorder. Such petition shall be accompanied by a showing that therepresentation is not false or misleading within the meaning of theFederal Trade Commission Act , and , if such has been the casethat the specific representation has been approved by the Secre-tary of the Department of Health , Education and Welfare underthe provisions of the Federal Food , Drug and Cosmetic Act as itis presently constituted or as it may hereafter be amended.

It is !uTtheT ordeTed That respondent shaH , within sixty (60)days after service upon it of this order , fie with the Commissiona report , in writing, setting forth in detail the manner and formin which it has complied with this order to cease and desist.

FINAL ORDER

This matter having been heard by the Commission on an appealby complaint counsel from the initial decision of the hearing ex-aminer , and upon briefs and argument in support thereof and inopposition thereto and the Commission having issued its Opinionherein; it is hereby

OrdeTed That the findings of fact and conclusions in the initialdecision of the hearing examiner which are inconsistent with theCommission s Opinion and the Findings of Fact and Conclusions

hereby entered be and hereby are set aside; and it is furtherOrdeTed That the attached Findings of Fact and Conclusions

as supplemented by the additional facts set forth in the Commis-sion s Opinion herein and the findings of fact and conclusions in

the initial decision not hereby set aside, be and hereby are

adopted and entered as the findings of fact and conclusions of theCommission; and it is further

Ordered That the order proposed by the hearing examiner be

and hereby is set aside and that the attached Order be and herebyis entered as the order of the Commission.

Documents

ers from the...AMERICAN HOME PRODUCTS CORP. 1525 1524 Complaint shrink, avoid need for sUl'gical treatment on, heal, cure, or remove hem- orrhoids or effect any other cure beyond temporary